Agency classClass IOur severity:Severe FDA (Devices)·Z-0004-2022·Announced 2021-10-20

Abbott SARS-CoV-2 Diagnostic Kit Recalled for Risk of False Positive Results

Abbott Molecular is recalling 60,563 units of the Alinity m SARS-CoV-2 Amp Kit due to potential false positive test results. The affected kits were distributed worldwide from September 2021 through January 2023.

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: This is an FDA Class I recall, which requires a minimum severity score of 4 per the rubric. Although no illnesses or injuries have been reported in the source text, the FDA's Class I classification indicates the agency determined the potential for false positive results in a diagnostic device presents a serious health consequence.

Plain-English summary

Abbott Molecular, Inc. is recalling 60,563 units of the Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and the associated Application Specification File. The FDA classified this as a Class I recall due to the potential for false positive results.

The recalled diagnostic kits were distributed worldwide, including throughout the United States and 35 other countries. Multiple lot numbers are affected, with expiration dates ranging from September 2021 to January 2023.

The hazard is a potential for false positive results. A false positive would mean a diagnostic test could incorrectly indicate infection when a person is not actually infected. The FDA's Class I classification indicates the agency determined this risk presents a serious health consequence.

Laboratories and healthcare facilities possessing the affected kits should discontinue use and contact Abbott Molecular for information about device replacement or alternative testing options.

The recalled product

Product: Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Manufacturer: Abbott Molecular, Inc.
Category: Medical Device — Diagnostic Test Kit
Hazard: false-positive
Affected units: 60,563

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: 09N78-095
UDI 00884999049222
Lot/Serial
Expiration: 511810
09/18/2021
512026
09/21/2021
512900
10/14/2021
513146
513583
11/18/2021
513959
11/23/2021
514176
514216
12/01/2021
514819
12/17/2021
515052

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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