The Recall Desk
SevereFDA (Devices)·Z-0007-2022·Announced 2021-10-20

Abbott Alinity m SARS-CoV-2 Test Kit Recalled for Potential False Positives

Abbott Molecular recalls its Alinity m SARS-CoV-2 Amp Kit (Non-US Assay), an in vitro diagnostic test, due to potential for false positive results. Approximately 11,408 units were distributed worldwide.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA classified this as a Class I recall. Per the severity rubric, FDA Class I recalls must receive a minimum score of 4 (Severe), regardless of other factors.

Plain-English summary

Abbott Molecular, Inc. is recalling its Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and related Application Specification File, which is used as an in vitro diagnostic test.

The recall is due to a potential for false positive results from the affected test kits.

Approximately 11,408 units were distributed worldwide, including across the United States, Australia, Austria, Belgium, Brazil, Canada, Colombia, Czech Republic, Estonia, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Malaysia, Montenegro, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam.

The recalled product

Product
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Manufacturer
Abbott Molecular, Inc.
Category
Medical Device — In Vitro Diagnostic
Hazard
Affected units
11,408

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 Number: 09N78-091
  • UDI 00884999049222
  • Lot/Serial
  • Expiration: 520596
  • 06/18/2022
  • 520952
  • 07/09/2022
  • 524054
  • 10/18/2022
  • 524965
  • 10/25/2022
  • 525462
  • 12/10/2022
  • 525768
  • 12/16/2022
  • 526708
  • 01/18/2023
  • 527842
  • 02/08/2023
  • List Number 09N78-03E

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

Related recalls

Same manufacturer · Abbott Molecular, Inc.

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Same hazard · false positive results

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