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.
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 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.
- Hazard
- false-positive
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.
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