The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0883-2022·Announced 2022-04-13

Abbott Alinity m HBV Device Misquantitation of Negative Samples

Abbott Molecular recalled Alinity m HBV Application Specification Files due to potential for incorrect high quantitation results on negative samples, which could affect test accuracy for hepatitis B virus detection.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: This is an FDA Class II medical device with a potential for measurement error that could affect diagnostic accuracy. No illnesses or injuries have been reported. This qualifies as a risk-of-harm product where injury has not yet been reported, meeting the High severity criteria.

Plain-English summary

Abbott Molecular, Inc. issued a recall for the Alinity m HBV Application Specification File (US and CE versions) used in hepatitis B virus testing. The issue involves a potential for misquantitation, where negative samples may be reported as having high quantitation results, potentially leading to inaccurate test outcomes.

This recall affects healthcare facilities and laboratories in the United States (Arizona, California, Illinois, Indiana, Massachusetts, Michigan, Missouri, New Hampshire, New Jersey, New York, Ohio, South Dakota, Texas, and Virginia) and internationally in Australia, Austria, Belgium, Brazil, Canada, Colombia, Czech Republic, El Salvador, Estonia, France, Germany, Israel, Italy, Japan, Latvia, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam.

The affected specification files are: 08N47-03A (US, Version 1.00), 08N47-01B (CE, Version 2.00), and 08N47-01C (CE, Version 3.00). The source documentation does not provide specific instructions for remediation or corrective actions.

The recalled product

Product
Alinity m HBV Application Specification File (US and CE)
Manufacturer
Abbott Molecular, Inc.
Category
Medical Device — Hepatitis B Testing
Hazard

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 (4)

  • List Numbers: 1) 08N47-03A (US)
  • Version 1.00 2) 08N47-01B (CE)
  • Version 2.00 3) 08N47-01C (CE)
  • Version 3.00

Distribution

Distributed in 14 states:

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 →

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