Agency classClass IOur severity:Severe FDA (Devices)·Z-0005-2022·Announced 2021-10-20

Abbott Alinity m Resp-4-Plex Respiratory Diagnostic Kit Recalled for False Positive Results

Abbott is recalling the Alinity m Resp-4-Plex AMP Kit, an in vitro diagnostic used for respiratory pathogen testing, due to potential for false positive results affecting approximately 8,469 units 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 Class I classification per agency designation. Per the severity rubric, FDA Class I recalls must be scored no lower than 4 (Severe), regardless of reported adverse health events.

Plain-English summary

Abbott Molecular, Inc. is recalling the Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and the Alinity m Resp-4-Plex Application Specification File, both used for in vitro respiratory diagnostic testing.

The product is being recalled due to a potential for false positive results.

Approximately 8,469 units have been 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 Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Manufacturer: Abbott Molecular, Inc.
Category: Medical Device — In Vitro Diagnostic / Respiratory Testing
Hazard: false-positives
Affected units: 8,469

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: 09N79-096
UDI 00884999049390
Lot/Serial
Expiration: 514074
09/15/2021
519243
05/10/2022
5/10/2022
522088
8/4/2022
522128
8/26/2022
523152
10/10/2022
524433
1/15/2023
526710
1/21/2023
527845
2/8/2023

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.

See all →

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Same hazard · false positives