Agency classClass IOur severity:Severe FDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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: false-positive-results
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 →

Same manufacturer · Abbott Molecular, Inc.

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