Events

Safety Alert for Commercial Name: IMMULITE 2000 Universal IgG Specific IgG Allergen Kit. ANTI-HBc IMMULITE 2000; BR-MA (CA15-3) IMMULITE; BR-MA (15.3) Immulite 2000; CEA IMMULITE; CEA IMMULITE 2000; CK-MB IMMULITE; CK - MB IMMULITE 2000; EPO IMMULITE; EPO IMMULITE 2000; FOLIC ACID IMMULITE 2000; IMMULITE GASTRINE / IMMULITE 1000; GASTRINA IMMULITE 2000; OM - MA IMMULITE; OM-MA IMMULITE 2000; THYROGLOBULIN IMMULITE; THYROGLOBULIN IMMULITE 2000; VITAMIN B12 IMMULITE / IMMULITE1000. Technical Name: IMMULITE 2000 Universal IgE Specific IgG Kit 3g. ANTI-HBc IMMULITE 2000; BR-MA (CA15-3) IMMULITE; BR-MA (15.3) Immulite 2000 ;. CEA IMMULITE; CEA IMMULITE 2000; CK-MB IMMULITE; CK-MB IMMULITE 2000 ;. EPO IMMULITE; EPO IMMULITE 2000; FOLIC ACID IMMULITE 2000 ;. IMMULITE GASTRINE / IMMULITE 1000; GASTRINA IMMULITE 2000; OM - MA IMMULITE ;. OM-MA IMMULITE 2000; THYROGLOBULIN IMMULITE; THYROGLOBULIN IMMULITE 2000; VITAMIN B12 IMMULITE / IMMULITE1000. ANVISA registration number :. 10345160916. 10345160914. 10345160914. 10345160814. 10345160812. 10345160812. 10345161894. 10345160745. 10345160727. 10345160827. 10345160712. 10345160718. 10345160916. 10345160916. 10345161009. 10345160877. 10345160871. 10345160825. Risk class (Sequential order of the registration number). II. IV. III. III. III. III. III. III. II. II. II. II. II. III. III. II. II. II. . Affected Model: N / A .. Serial Numbers Affected:. REAG ALLERGY UNIV IGE 600T (IMM2000): 447; 448; 450; 451; 453; 456; 457; 458; 459; 461; 462; 465; 466; 468; 469 .. FOLIC ACID REAGENT 200T (IMM2000): 494; 496; 498; 502; 503; 505; 506; 508 .. REAGENT FOLIC ACID 600T (IMM2000): 492; 495; 497; 504 .. ANTI-HBC 200T REAGENT (IMM2000): 577; 578; 579; 580. REAGENT BR-MA 15.3 200T (IMM2000): 262; 263; 264; 265; REAGENT CEA 100T (IMM1000): 353; 354; 355; REAGENT CEA 200T (IMM2000): 307; 308; 309; 310; 311; REAGENT CEA 600T (IMM2000): 307; 308; 309; 310; 311 .. REAGENT CKMB 100T (IMM1000): 342; 343; 344; REAGENT CKMB 200T (IMM2000): 238; 239; EPO MONO REAGENT (IMM1000): 343; 347. EPO MONO REAGENT (IMM2000): 246; 247; 248; 249; 250; 251; 252 .. REAGENT GASTRINE 200T (IMM2000): 248; 249; 250; 251; 252; 253; 254 .. OM-MA CA125 100T REAGENT (IMM1000): 209; 211; 212; 2013. REAGENT OM-MA CA125 200T (IMM2000): 285; 286; 287; REAGENT TIROGLOBULIN 100T (IMM1000): 286; 287; 288; 289; 290. TIROGLOBULIN REAGENT 200T (IMM2000): 340; 341; 342; 344; 345; 346; 347; 349; 351; 352; REAGENT VITAMIN B-12 100T (IMM1000): 336; 337; 338; 339; 340;

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostics Products Ltd..

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
    2468
  • Date
    2018-01-11
  • 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
    Mitigations include correlation with clinical history and presentation, as well as with other laboratory diagnostic tests, serial tests, and / or concomitant with imaging studies, depending on the analyte. Siemens does not recommend reviewing the results. Users and customers should consult the information provided in the Notification Letter until the updates to the instructions for use (IFU) regarding biotin interference are completed. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 12/12/2017 - Date of notification notice to Anvisa: 11/01/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Reason
    Siemens healthcare diagnostics has confirmed through internal research that the assays listed in the product data annex of the immulite® / immulite® 1000 / immulite® 2000 / immulite® 2000 xpi systems are susceptible to biotin interference. this occurs when biotin in patient samples interferes with the architecture of the streptavidin-biotin assay on the immulite platform. biotin interference promotes a potential bias in the results of these assays. instructions for use (ifu) currently do not list biotin as a potential interferer.
  • Action
    Field Action IMC Code 18-02 triggered under the responsibility of Siemens Healthcare Diagnósticos Ltda. It will update, correct or supplement the instructions for use.

Device

Commercial Name: IMMULITE 2000 Universal IgG Specific IgG Allergen Kit. ANTI-HBc IMMULITE 2000; B...

Manufacturer

Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostics Products Ltd.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA