Agency classClass IOur severity:Severe FDA (Devices)·Z-0008-2022·Announced 2021-10-20

Abbott Respiratory Diagnostic Kit Recalled for Potential False Positive Results

Abbott Molecular is recalling the Alinity m Resp-4-Plex AMP Kit due to potential false positive results. The recall affects 5,855 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 establishes a minimum severity of 4 per the recall rubric. Although no illnesses or injuries are reported in the source text, the potential for false positive results in a respiratory diagnostic device represents a serious risk to patient care through diagnostic error.

Plain-English summary

Abbott Molecular, Inc. is recalling the Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and its Application Specification File. The FDA classified this as a Class I recall due to a potential for false positive results in respiratory virus testing.

The recall affects 5,855 units distributed worldwide 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. Specific lot numbers and expiration dates have been identified by the FDA.

No illnesses or injuries have been reported in association with this issue. Laboratories and healthcare facilities using affected lots should contact Abbott Molecular for instructions on product replacement or corrective actions.

The recalled product

Product: Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Manufacturer: Abbott Molecular, Inc.
Category: Medical Device — In Vitro Diagnostic
Hazard: false-positive
Affected units: 5,855

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: 513424
10/13/2021
513771
513861
11/06/2021
514503
11/19/2021
515652
12/02/2021
516411
517877
518436
12/10/2021
518877
519091
519243
05/10/2022
519582

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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