FDA Enforcement
Class II
Ongoing
Alinity i Anti-HCV Reagent Kit, List Number 08P0521
Recall: Z-1480-2024
·
Reported April 10, 2024
Enforcement
- Recall Number
- Z-1480-2024
- Event ID
- 94205
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Abbott GmbH
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 10, 2024
- Initiation Date
- March 4, 2024
- Classification Date
- April 4, 2024
- Address
- Max-Planck-Ring 2, Wiesbaden, N/A, Germany
Description
Alinity i Anti-HCV Reagent Kit, List Number 08P0521
Reason
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).
Code Info
UDI/DI 00380740130657, Lot Numbers: 52020BE00, 54149BE00, 56384BE00, 58172BE00, 59203BE00
Distribution
US Nationwide distribution.
Quantity
5110 units