Events

Safety Alert for Trade Name: Hemoglobin Analyzer System; ANVISA registration number: 80020690313; Risk class: II; Affected model (s): D-10; Lot (s) / Serial numbers pertaining to the sample carrier (accessory of the D-10 Hemoglobin Analyzer System) used in conjunction with the hemoglobin analyzer: DR3D787812, DR3F803105, DR3F803104, DR4D878307, DR4F888608, DR4D878308, DR4D878309, DR4D878310, DR4F888602, DR4F888601, DR4D878312, DR3G803201, DR4F888603, DR4D878311, DR3A763707, DR3A763705.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Bio-Rad Laboratórios Brasil Ltda; Bio-Rad Laboratories Inc.

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
    1801
  • Date
    2015-01-21
  • 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
    The company should clarify that the serial numbers reported refer to the Rack Loader, a sample loader, which is an optional accessory for routine laboratories. The risk is directly related to the joint use of the in-vitro diagnostic equipment "D-10 Hemoglobin Analyzer System" and the sample loader, there being no risk of using the equipment without this accessory, therefore, this field action involves the serial numbers of the sample loaders distributed in Brazil. Thus, we reiterate that only users of the "D-10 Hemoglobin Analyzer System" equipment that have the Rack Loader accessory, sample loader, are subject to the risk.//// There is a possibility of incorrect treatment for patients if the laboratory does not review the results before the release ./// The company will release a new statement once it has a definitive solution to the problem.
  • Reason
    There is a possibility that the result of a sample is incorrectly assigned to the patient when the system is operating with the sample loader attached to the equipment.
  • Action
    a) Classification of the risk: Class III; b) Classification of the field action: communication to customers, letter sending; c) Field action code: FSCA_001-15; and d) recommendations to users and patients: As soon as you are reviewing the test results, please make sure that the amount of released results corresponds to the total of analyzed samples. If there is a discrepancy between the quantities, physically identify the sample whose result is missing, process all samples from the sample loader again, and review the results on your Laboratory Information System (LIS).

Device

Trade Name: Hemoglobin Analyzer System; ANVISA registration number: 80020690313; Risk class: II; ...

Manufacturer

Bio-Rad Laboratórios Brasil Ltda; Bio-Rad Laboratories Inc