Summary
The FDA issued a Class II for Alinity i Anti-HCV Reagent Kit, List Number 08P0521 by Abbott GmbH. Reason: Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed.
Details
Source
Device Recall
External ID
Z-1480-2024
Action Date
2024-04-10
Status
Ongoing
Category
device
Product Description
Alinity i Anti-HCV Reagent Kit, List Number 08P0521
Lot/Code Info: UDI/DI 00380740130657, Lot Numbers: 52020BE00, 54149BE00, 56384BE00, 58172BE00, 59203BE00
Quantity Affected: 5110 units
Reason for Recall
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).
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-04
Company
Wiesbaden
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 200 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Abbott GmbH has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abbott GmbH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abbott GmbH have FDA actions?
Abbott GmbH has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1480-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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