FDA-Device2024-04-10Class II
Alinity i Anti-HCV Reagent Kit, List Number 08P0521
Abbott GmbH
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).
Sold states
US Nationwide distribution.
Affected count
5110 units
Manufactured in
Max-Planck-Ring 2, Wiesbaden, Germany
Products
Alinity i Anti-HCV Reagent Kit, List Number 08P0521
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1480-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief