Recall Z-0884-2022— Abbott Molecular, Inc.
Class II · Ongoing
Class II FDA medical device recall by Abbott Molecular, Inc., initiated 2022-03-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Alinity m HBV AMP Kit (US and CE). Reason: There is a potential for misquantitation high results for negative samples..
- Recalling firm
- Abbott Molecular, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-03-04
- Firm location
- Des Plaines, IL, United States
Product description
Alinity m HBV AMP Kit (US and CE)
Reason for recall
There is a potential for misquantitation high results for negative samples.
Data sourced from openFDA. This site is unofficial and independent of the FDA.