Events

Safety Alert for Trade name: Family of differentials for identification of microorganisms - Vitek 2 Identification Technical name: Vitek 2 cards Identification Registration number ANVISA: 10158120571 Hazard class: II

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by bioMérieux Brasil Indústria e Comércio de Produtos Laboratorias Ltda.; bioMérieux 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
    2276
  • Date
    2017-04-25
  • 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
    1-It is not necessary to discard all the cards belonging to the impacted lot. 2- We recommend that a careful visual check be made of each card belonging to the affected lot before use. 3- Compare lot numbers in your inventory with the lot numbers listed in Appendix A of the customer letter. 4- For impacted batches, visually inspect cartons for defects on both sides. ### Update of the field action: UPDATED ON 10/25/2017, the company presented the report of completion of the field action proving the sending of the security warning to the client with evidence of science and all actions completed. If a defect is observed, discard the corresponding card (s) and contact your bioMérieux representative for credit or replacement. 5- If the defect is not observed, continue testing the cards according to your standard procedure, but increase the monitoring of results for possible test errors if a visual inspection can not identify all of the affected ID / AST cards. Repeat the tests which you observe results potentially indicative of a defect in the package, such as: 5.1 A resistant Imipenem result, particularly if not expected and / or inconsistent with other results; 5.2 A resistant or intermediate result of Nitrofurantoin which is unusual or inconsistent with other results; 5.3 A resistant result of Oxacillin or Erythromycin which is unusual or inconsistent with other results; 5.4 Any Quality Control test with these antimicrobial agents that show results outside the expected range. 6- If imipenem is not tested, review other beta-lactams such as penicillins, other carbapenems, and / or cephalosporins for results with inconsistent or unusual resistance, which may also indicate a potential defect in packaging. If there are doubts after repeated testing, alternative methods of establishing antimicrobial susceptibility should be used. If you suspect an unrelated performance error, please follow your normal troubleshooting procedure. Other Actions Related to Notification: 7- Please ensure that this letter is distributed and reviewed by all persons involved in your laboratory. 8- Please file this letter along with the bioMérieux documentation on VITEK® 2. Fill out the attached Receipt Form and return to the digitized bioMérieux by contacting contato@biomerieux.com as soon as possible.
  • Reason
    We have reported that damage to the packaging of vitek cards (white packaging bags) can lead to moisture entering the bags, which impacts card performance due to the degradation of the antibiotic with consequent loss of power. this could explain the increased resistance to antibiotics experienced by some clients. research has shown that the root cause of the problem was the combination of the wheel design of the sealing point x positioning in the manufacturing equipment x shipping and handling of the products. the investigation concluded that the card stock integrity problem potentially impacted 204 card types (504 lots). the material of the white bag is composed of 05 layers, 04 of which are clear. all 5 layers may be compromised by moisture entering the bag. based on the internal test about 20% of the bags presented visual defect. most bags with visual defects had integrity (eg no moisture in the bags). however, even with careful visual inspection, 1 in 200 (0.5%) may be compromised. the root cause was identified and a corrective action was taken, the sealing point wheel and the manufacturing equipment were changed with a new design. the new design of the sealing point is smooth, for better sealing with fewer edges susceptible to failure. there is no evidence of card stock whose integrity is compromised after such modification.
  • Action
    Field Action Code FSCA 3445 triggered under the responsibility of the company bioMérieux Brasil Indústria e Comércio de Produtos Laboratorias Ltda. Company will send letter to customers.

Device

Trade name: Family of differentials for identification of microorganisms - Vitek 2 Identification...

Manufacturer

bioMérieux Brasil Indústria e Comércio de Produtos Laboratorias Ltda.; bioMérieux Inc.