ARCHITECT Anti-HCV Reagent Kit recall
ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
Why was ARCHITECT Anti-HCV Reagent Kit 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).
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a) 1L79-25, 00380740001414, Lot Numbers: 52011BE00, 54140BE00, 56375BE00, 58163BE00, 59194BE00; b) 1L79-35, 00380740001421, Lot Numbers: 52015BE00, 54144BE00, 56379BE00, 58167BE00, 59198BE00
- Product
- ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
- Recalling firm
- Abbott GmbH
- Quantity
- 7219 units
- Distribution
- US Nationwide distribution.
- Recall date
- April 10, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)