Events

Safety Alert for VITROS for Glucose GLUT / Lactate LAC / TRIGLYCERIDES TRIG / URIDO URIC Technical Name: Glucose / Lactate / TRIGLYCERIDES / URIC ACID Registration Number ANVISA: 10132590235 Hazard Class: II Affected Model: Dry Reactive VITROS for Glucose GLU / Lactate LAC / TRIGLYCERIDES TRIG / URIC ACID URIC Serial Numbers Affected: SKU: 1707801 | Lots: GENs 10, 11, 20 to 31; SKU: 8433880 and 8150112 | Lots: GENs 30, 31; SKU: 1336544 and 8329930 | Lots: GENs 16, 17, 19, 20, 22, 23, 24, 25, 27 to 32; SKU: 1943927 | Lots: GENs 26, 27, 28, 29, 31 Due to the volume of impacted products, the company chooses to notify all customers that possess the equipment that can be used for such dry reagents. Therefore, customers who have the VITROS 250/350, 4600, 5600 and / or 5.1 FS System equipment will be notified.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho Clinical Diagnostics.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2105
  • Date
    2016-09-12
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Extra notes in the data
    • Before receiving the revised Instructions for Use (IFU), be aware that misaligned results may occur in patient samples containing these substances. Follow your normal laboratory procedures, as you would for other known test interferences. Note: It is acceptable to continue using the affected VITROS Dry Reaction Tests. • Talk to your Lab Medical Director about any questions regarding previously reported results to determine the appropriate course of action. • Place this notification on your VITROS System or along with your user documentation. • In compliance with regulatory requirements, complete the Receipt Confirmation Form.
  • Reason
    Ortho clinical diagnostics (ortho) became aware of new information on the potential for n-acetylcysteine ​​(nac) interference in some specific tests with the vitros dry reagents for glucose, lactate, triglycerides and uric acid. patients who received nac may potentially have sample results with deviations. because of this problem, we are initiating this urgent product fix. n-acetylcysteine ​​is a drug primarily used to treat paracetamol overdosage, but the drug is also used as a mucolytic therapy in the treatment of lung diseases and inhalation injury in children. nac is also used as a nutritional supplement.
  • Action
    Field Action Code 16000112 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Company will update, correct or supplement the instructions for use.

Device

VITROS for Glucose GLUT / Lactate LAC / TRIGLYCERIDES TRIG / URIDO URIC Technical Name: Glucose /...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho Clinical Diagnostics