Safety Alert for ARCHITECT HAVAb-IgG - Affected Lots: 07658LI00, 07659LI00, 09297LI00, 09298LI00, 09299LI00, 09300LI00, 10326LI00, 10327LI00, 10327LI00, 10331LI00, 10341LI00, 103364LI00, 13365LI00, 14105LI00, 14106LI00, 15229LI00, 15230LI00, 16298LI00, 16299LI00, 16300LI00, 16301LI00.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ABBOTT LABORATÓRIOS 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
    A false positive result for anti-HAV IgG would lead the doctor to mistakenly believe that the patient is immune to HAV. This could result in a lack of vaccination that may increase the risk of HAV infection. Probability: The risk is mitigated by the probability of damage. The frequency of occurrence of the risk is 11%, in the worst case. HAV may progress to a fulminating course with worse outcome in only 0.1% of cases. Not all individuals who have not been vaccinated may be infected during their lifetime. The likelihood of serious injury is rare. The total risk to be considered is Medium. Anvisa follows this action.
  • Reason
    Affected batches present a change in serum and plasma results, generating higher s / co values ​​over time, which may lead to lower specificity and greater occurrence of false-positive results.
  • Action
    Review the shelf life of the reagent kits: Check Annex I shipped in the communication. Make sure you have any of the lots of reagents listed in stock. Check the expiration date for all batches of reagents identified in your stock according to the instructions in Attachment 1 sent in the communication made. After applying the new expiration dates to the reagent kits listed in the Annex, discontinue use of the kits that are now due, and segregate the material according to your laboratory procedure. Send the answer letter with the amount of kits to be collected in your laboratory. Apply the following interpretation of results after reviewing the shelf-life of reagent kits: No mean is required for Serum samples processed using batches that are within expiration date. When the results are generated with plasma samples in the range of 1.00 to 3.55 S / CO, additional tests, for example with a secondary method, are recommended to confirm the result. ATTENTION: The above measures should be taken as a precaution until permanent preventive measures are implemented. Results previously obtained: Results released with lots of ARCHITECT HAVAb-IgG reagents listed in the Annex sent in the communication to clients are not impacted under the following conditions: a) The result was <1.00 S / CO or> 3.55 S / CO. b) The results were generated with serum samples within the new shelf life (as per the annex sent in the communication). Results that do not meet conditions a) or b) above may be impacted. Abbott recommends that clients follow their lab procedures when discussing these results with requesting physicians.