Reported Apr 10, 2024 · Ongoing
ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
Abbott GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott GmbH · Max-Planck-Ring 2 · Wiesbaden · N/A
Is this the product you have?
- ARCHITECT Anti-HCV Reagent Kit
- List Numbers
a) 1L79-25b) 1L79-35
- Lot codes and dates
a) 1L79-2500380740001414
- Lot Numbers
52011BE0054140BE0056375BE0058163BE0059194BE00b) 1L79-3500380740001421
- Lot Numbers
52015BE0054144BE0056379BE0058167BE0059198BE00
- Amount recalled
- 7219 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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