Alinity m HBV AMP Kit Recalled for Risk of Falsely High Test Results
Abbott Molecular is recalling the Alinity m HBV AMP Kit due to potential for falsely high results on negative samples. The kits are used for Hepatitis B virus testing in the US and internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II diagnostic test system with potential for false positive results on negative samples. Per the severity rubric, risk-of-harm products without reported injuries are classified as High.
Plain-English summary
Abbott Molecular is recalling the Alinity m HBV AMP Kit, a diagnostic testing system for Hepatitis B virus detection and quantification. The recall affects both US and international (CE marked) versions of the kit.
The reason for the recall is a potential for the kit to produce falsely high quantitation results when analyzing negative samples—samples that should show no detectable Hepatitis B virus. These incorrect high results could lead to misinterpretation of patient test results.
The recall affects approximately 4,966 kits that have been distributed to healthcare laboratories and facilities in the US (Arizona, California, Illinois, Indiana, Massachusetts, Michigan, Missouri, New Hampshire, New Jersey, New York, Ohio, South Dakota, Texas, and Virginia) and in more than 40 countries worldwide. Abbott Molecular has identified specific lot numbers for the affected kits.
Laboratories and healthcare facilities that possess affected kits should contact Abbott Molecular immediately for replacement kits, corrective actions, or further guidance. Users should follow any instructions provided by Abbott regarding testing practices with potentially affected material.
The recalled product
- Product
- Alinity m HBV AMP Kit (US and CE)
- Manufacturer
- Abbott Molecular, Inc.
- Category
- Medical Device — Diagnostic Kit
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- List Numbers: 1) 08N47-095 (US)
- Lots: 519756
- 523799
- and 524361
- Updated to add: 381583
- 529391
- 529687
- 530273
- 531598
- 2) 08N47-090 (CE)
- Lots: 519755
- 520957
- 522137
- 523798
- and 524059
- Updated to add: 380963
- 380979
- 381021
- 529378
- 529686
Distribution
Part of a larger recall action
This product is one of 2 recalled by Abbott Molecular, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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