FDA-Device2024-04-10Class II
ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
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
7219 units
Manufactured in
Max-Planck-Ring 2, Wiesbaden, Germany
Products
ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1479-2024Don't want to check this manually?
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