Abbott GmbH 2024-04-10 Health serious FDA
Health · FDA · Recall #FDA-Z-1479-2024
ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35 Recall
Issued April 10, 2024 · Abbott GmbH
In April 2024, Abbott GmbH recalled the ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: " ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79). " Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).
What you should do
- 1 Stop using ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Abbott GmbH to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Abbott GmbH
- Category
- Health
- Recall date
- April 10, 2024
- Units affected
- Not reported
- Sold at
- US Nationwide distribution.
- Recall number
- FDA-Z-1479-2024
- Made in
- Germany
- Issuing agency
- FDA
In context
- Abbott GmbH has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.