Alinity m HBV AMP Kit Recalled for Risk of Falsely High Test Results

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

Hazard

• misquantitation
• false-positive

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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