Medical Device Recall: Alinity i Anti-HCV Reagent Kit, List Number 08P0521
Abbott GmbH · March 4, 2024
Reason for Recall
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).
Distribution
US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
5110 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1480-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.