Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Extra notes in the data
Reason
The manufacturer has identified that, when using the architect dhea-s reagent kit, samples from babies up to 60 days of age may have false results. the manufacturer is currently investigating the specific cause of the elevated results. although false elevations have been observed in infants up to 60 days of age, the reference range for children up to 10 years of age given in the test instruction manual should also not be used as the reference ranges are being tested.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Extra notes in the data
Reason
The results obtained using the affected batches may be falsely elevated and that may indicate a positive shift over the results obtained. using previous batches of reagents and / or calibrators. this shift may affect reference intervals of the architect intact pth test determined in a particular laboratory, whereby abbott architect intact pth controls do not detect displacement. as regards the diagnosis of diseases related to disorders of calcium metabolism, these false elevated results may lead the doctor to think that the patient is suffering from hyperparathyroidism, or to fail to diagnose hypoparathyroidism. these findings would be inconsistent with the clinical picture and / or with the results of other tests and could lead to new patient testing and short-term placement delays diagnoses in chronic diseases.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Extra notes in the data
Reason
The manufacturer of the 'abbott ireland diagnostics division' has found that 17% of the total reagents labeled with serial numbers 38901ui00 and 38901ui01 are able to give lower 'relative light units' ('rlu' s) readings than expected, which may have values out-of-range controls or patient outcomes that may be higher than expected.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Extra notes in the data
Reason
The manufacturer has determined that the cell-dyn emerald analyzer in some cases reports that the quality control results for the parameters "rbc" (erythrocytes) and "plt" (platelets) are outside the lower range.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Extra notes in the data
Reason
Abbott diagnostics withdraws phenobarbital reagents with numbers from the clinical chemistry market series 62299un12 and 85773un12 due to inaccuracy that increases with age of the reagent. the imprecision of the phenobarbital test is ≤ 7% of the total cv%; however, cv confirmed by internal testing was approximately 12% for all current reagent batches older than 5 months. the reagent with series number 52803un12, which has already expired, has also shown imprecision.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Extra notes in the data
Reason
Acist received reports about the entry of air into the injection tube. however, there was no evidence or report of any injection of air into the patient, injury or adverse health effects.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Extra notes in the data
Reason
The manufacturer decided to withdraw the specified batches of the medical device because of the possibility that these six batches would produce elevated results in patients. abbott controls cannot detect this result elevation and their values are within range.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Extra notes in the data
Reason
Abbott has found that architect 25-oh vitamin d test can show false high or low results in usage with rv (7c15-01). the manufacturer's investigation determined the potential range of false elevated or false lower results, as well as the frequency of discrepancies in the results of patient sample analyzes.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Extra notes in the data
Reason
The lipase reagent instruction manual contains misinformation about the required cuvette rinsing procedure (smartwash) for the triglyceride test. the instruction manual states that the cuvette flushing step ("smartwash") in the "triglyceride" test is not required in "architect system" software version 7.00 or higher; however, triglyceride smartwash is required for the lipase test in all software versions.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Extra notes in the data
Reason
According to the report of the manufacturer, during the maintenance of the condenser or during charging for the high-voltage therapy of the active implantable medical device "st. jude medical ellipse vr / dr - implantable cardioverter defibrillator (icd), the message "capacitor charge time limit reached" may appear due to a fault with the high voltage capacitor. this error may delay the delivery of high-voltage therapy or suspend delivery of part or all of the programmed high-voltage shocks. as a result of this error, there were no serious injuries or deaths reported to "st. jude medical. ".
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Extra notes in the data
Reason
Erosion, although rare, is a potentially serious and life-threatening occurrence with symptomatic signs including chest pain, shortness of breath, shortness of breath and shortness of breath. if erosion occurs, immediate intervention may be necessary for a successful outcome. the risk of potential erosion remained stable. worldwide incidence estimate for erosion is between 0.1% and 0.3%.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Extra notes in the data
Reason
Thoratec has become aware of a recent trend in reports of serious injuries and deaths associated with the process of changing from a primary system controller to their backup system controller in patients using the "pocket" system controller model. the system controller is the external unit that controls the function of the implanted heartmate ii left ventricular assist device.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Extra notes in the data
Reason
The manufacturer has reported that when lot 00092789 of said medical device is used, weak and non-homogenized red signals are obtained. if the user follows the procedures recommended in the section "quality control" of the instructions for use of the medical device, this signal will eliminate, and the result obtained will not be considered, and if the recommended procedures in the section "quality control" are not followed, this result will be interpreted as weak or false negative.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Extra notes in the data
Reason
The certificate of analysis ("coa") and the inner pack of "monoclonal mouse anti-human cdx2, clone dak-cdx2" (m3636) contain an error in the protein concentration value of 292.7 mg / l, which is sixteen times greater than the correct concentration. which is 18.3 mg / l. the "monoclonal mouse anti-human cdx2, clone dak-cdx2" (m3636) medical device will perform its function according to the manufacturer's intention, that is, this error does not affect the quality, performance or effectiveness of the medical device. therefore, there is no change in the concentration itself, and the outer packaging indicates the correct concentration of 18.3 mg / l. if the product is diluted with an inaccurate concentration greater than 292.7 mg / l, a diminished color strength will be seen, resulting in poor or negative coloration. this should be easy to detect both in internal positive normal tissue and in recommended positive external process controls. to date, the manufacturer has received only one complaint from the user, who noticed this during testing, and no adverse effects have been reported on any patient.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Extra notes in the data
Reason
The manufacturer has reported that when lot 00092789 and lot 20002057 of said medical device are used, weak and non-homogenized red signals are obtained. reduced activity of one batch of enzyme-antibody conjugates has been identified as a major cause of weak red signals. if the user follows the procedures recommended in the section "quality control" of the instructions for use of the medical device, this signal will eliminate, and the result obtained will not be considered, and if the recommended procedures in the section "quality control" are not followed, this result will be interpreted as weak or false negative.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Extra notes in the data
Reason
Due to the fact that the manufacturer has recently received complaints from users stating that the sponge soaked with a povidone-iodine solution is completely separated from the cap, partially protruding from the cap, or even missing. using a minicap product that is damaged or missing a sponge with povidone-iodine may compromise the ability of the product to provide a sterile protective barrier at the end of the inter-catheter when the patient undergoes dialysis. this can cause an increased risk of peritonitis. then, using minicap products where the sponge partially protrudes from the cap may encourage improper aseptic technique, such as accidentally touching the sponge to move inside the cap. this can cause an increased risk of peritonitis. the manufacturer notes that there have been no reported adverse events regarding this product series.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Extra notes in the data
Reason
Bvp received four complaints where bard dualok breast lesion localisation wires damaged packaging and the wires protruded from the packaging. … if you have already used the affected devices, it is advisable to closely monitor the patients and the medical managment should be at the discretion of the treating physician.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Extra notes in the data
Reason
The manufacturer has recently received a number of complaints from users regarding "hd conventional lines" due to the sudden bursting of the pre-dialysis artery expansion chamber during various stages of treatment. after investigation, the manufacturer concluded that variations in the formulation of the material occurred, which could lead to increased material brittleness and reduced impact resistance. risk of cracking of the pre-dialysis arterial expansion chamber may lead to blood spatter. failure to detect this can lead to serious blood loss. also, this phenomenon poses a biological risk to third parties.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Extra notes in the data
Reason
It has been noted that users may not follow the instructions given in the instruction manual and improperly open the pack of disposable kits when setting up peritoneal dialysis (pd) therapy, damaging the homechoice pro cassette.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Extra notes in the data
Reason
An integral part of the homechoice pro is an air (pneumatic) pump.Certain sounds like buzzing, whistling, clicking and venting (air release) are expected and common during the operation of the appliance.Amplifying these sounds at certain stages of the camera's operation is also common.However, if any of these sounds increases significantly or a new sound occurs that was not previously heard during the operation of the appliance, the user should inform his doctor and / or sister or the manufacturer's representative.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Extra notes in the data
Reason
As part of the safety corrective action, the manufacturer modifies the labeling method of the medical device, as well as supplementing the instructions for use, adding warnings and precautions not previously stated. this safety-corrective measure was not initiated because of an increase in the incidence of adverse drug reactions, but as a result of increased patient safety concerns. homechoice is not intended to be a substitute for a nephrologist in monitoring the patient's overall condition. using this device without monitoring the patient's condition may result in serious injury or death.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Extra notes in the data
Reason
The manufacturer has given a notice accompanying the instruction manual for the "homechoice / homechoice pro" system, which provides specific instructions for patients if there is a suspected increased intraperitoneal volume ("iipv"), also known as "overfill". specifically, "iipv" is an inherent risk of peritoneal dialysis therapy. the condition is characterized by an unintended excess fluid in the peritoneal cavity that may become symptomatic, especially in high-risk population groups (infants, infants, young children and all patients with significant cardiac or pulmonary diseases). dialysate overfill (iipv) or insufficient dialysate leakage during "pd" therapy may lead to excess fluid in the abdomen of the patient followed by appropriate specific symptoms.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Extra notes in the data
Reason
Clinicians using homechoice to treat patients diagnosed with end-stage kidney disease with ascites should be aware that homechoice will attempt to drain the patient to discharge at the beginning of therapy ("initial extract"). with homechoice 10.210 software, the user was allowed to stop the active initial spill and then bypass it. with homechoice 10.4 software, this functionality has been removed. drainage to discharge in patients with ascites-diagnosed comorbidity is associated with an increased risk of hypotension and serious impairment of their hemodynamic status.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Extra notes in the data
Reason
Baxter healthcare, as part of a safety corrective measure, issued an important notice on a medical device to indicate the possible occurrence of elevated intraperitoneal volume (iipv), if total ultrafiltration (total uf) and minimum volume east (mdv%) are not properly programmed in tidal automatic peritoneal dialysis (tidal apd). iipv can lead to serious injuries or death due to: hernia of the abdominal wall or hernia of the diaphragm, then hydrothorax, heart failure, acute hypertension, pulmonary edema, decreased pulmonary function and pericardial effusion. children and patients who do not communicate are significantly more vulnerable because they are smaller and / or unable to indicate symptoms, by communication. other populations that are more vulnerable are critically ill patients and patients who are pulmonary or hemodynamically unstable.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Extra notes in the data
Reason
The manufacturer has issued a safety corrective measure in the field that will indicate to the user the errors in the currently valid instruction manual for the use of the specified medical device.