Safety Alert for IMx HIV-1 HIV-2 III Plus Reagents (List No. 8C98-20). IMx HIV-1 HIV-2 III Plus Controls (List No. 8C98-12). Westen Blot HIV Blot 2.2 (List # 2F02-01 and 8E02-01)

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ABBOTT LABORATORIOS DO BRASIL LTDA..

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
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    Brazil - 03/14/2002, the company informs that it has followed the program of product collection, through verbal communication measures to all customers, started on January 28, 2002; Formal communication initiated on 01.02.2002, sent to clients; correspondence sent to distributors. Products Collected: Western Blot HIV Blot 2.2 - No. 2F02-01, lots # AE0087, AE0088, AE0098, AE0100. AE0101 and AE1006. Western Blot HIV Blot 2.2 - List # 8E02-01 - Lots numbers: AE1021, AE0102, AE0096, AE1001, AE1008, AE1011, AE1017, AE1024, AE1031 and ae1034. IMx HIV-1 HIV-2 III Plus Reagents (List No. 8C98-20) - Lots numbers: 78172LU03, 80180LU01, 80180LU03, 80180LU04 and 81246lU03. IMx HIV-1 HIV-2 III Plus Controls (List No. 8C98-12) - Lots numbers: 76085HP00 and 80346HP00.
  • Reason
    Unsatisfactory for internal labels and instruction manual, for not presenting information in portuguese according to bulletin of analysis nº 4157.00 / 01, nº 4158.00 / 01, n ° 4159.00 / 01 and 4160.00 / 01 of the incqs.
  • Action
    The Technical Board of the Sanitary Surveillance Center of the State Health Secretariat SÃO PAULO, through CVS 27/02 - GT 4 DITEP, notified that the results of the analysis of these products revealed unsatisfactory. It determined the prohibition of marketing and use of all the units of the batch of the product in question, collection by the undertaking of all units of the batch marketed and other supplies under the same conditions; presentation by the company of the report on the payment made to the local VISA; that the establishments acquiring the products of the said company make due notification to corresponding regional VISA for complementary measures.