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Abbott GmbH recalls Alinity i Anti-HCV Reagent Kit, List Number 08P0521
Recalled April 10, 2024 · FDA recall Z-1480-2024 · Abbott
Hazard
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). · FDA Class II
Units
5110 units
Sold at
US Nationwide distribution.
Description
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).
Product
Alinity i Anti-HCV Reagent Kit, List Number 08P0521
Manufacturer(s)
Abbott GmbH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →