Abbott Alinity m SARS-CoV-2 Amp Kit Recalled for Potential False Positive Results
Abbott Molecular has recalled 71,314 units of the Alinity m SARS-CoV-2 Amp Kit due to potential false positive results. The kit was 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 classification of Class I requires a minimum severity score of 4. The recall involves potential false positive results in a SARS-CoV-2 diagnostic test, which could affect test accuracy.
Plain-English summary
The Alinity m SARS-CoV-2 Amp Kit, manufactured by Abbott Molecular, Inc., has been recalled due to potential false positive results. The kit is an in vitro diagnostic device used for SARS-CoV-2 testing.
A total of 71,314 units have been recalled. The affected kits were distributed worldwide, including 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 recall involves multiple lot numbers with expiration dates ranging from September 2021 through February 2023.
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.
- Category
- Medical Device — Diagnostic Test
- Hazard
- Affected units
- 71,314
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: 09N78-090
- UDI UDI 00884999049222
- Lot/Serial
- Expiration: 511468
- 09/15/2021
- 511504
- 511505
- 512025
- 09/21/2021
- 512416
- 09/18/2021
- 512417
- 512705
- 512712
- 10/07/2021
- 512898
- 513147
- 10/14/2021
- 513629
- 11/18/2021
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.
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