Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Alinity i Anti-HCV Reagent Kit Recalled by Abbott GmbH Due to Customer complaints were received regarding falsely elevated results...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Abbott GmbH directly.
Affected Products
Alinity i Anti-HCV Reagent Kit, List Number 08P0521
Quantity: 5110 units
Why Was This 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).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Abbott GmbH
Abbott GmbH has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report