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.
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 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.
- Hazard
- false-positive-results
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.
Related recalls
Same category
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27