Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

Class I - Dangerous

🏥 Medical Devices Recalled: September 2, 2021 Abbott Molecular Diagnostic Equipment Nationwide

What Should You Do?

Check if you have this product:
List Number: 09N78-090, UDI UDI 00884999049222; Lot/Serial, Expiration: 511468, 09/15/2021; 511504, 09/15/2021; 511505, 09/15/2021; 512025, 09/21/2021; 512416, 09/18/2021; 512417, 09/18/2021; 512705, 09/21/2021; 512712, 10/07/2021; 512898, 10/07/2021; 513147, 10/14/2021; 513629, 11/18/2021; 514359, 12/01/2021; 514762, 12/17/2021; 515053, 01/05/2022; 515415, 01/15/2022; 515416, 01/15/2022; 515948, 01/28/2022; 516084, 02/05/2022; 516430, 02/17/2022; 516431, 02/18/2022; 516612, 02/25/2022; 516636, 03/01/2022; 516910, 03/04/2022; 516911, 02/11/2022; 517009, 02/18/2022; 517138, 02/25/2022; 517354, 03/08/2022; 517876, 03/19/2022; 517998, 03/19/2022; 518668, 04/01/2022; 518669, 04/20/2022; 518878, 04/20/2022; 519022, 04/30/2022; 519122, 04/30/2022; 519372, 05/03/2022; 519373, 05/11/2022; 519784, 05/18/2022; 519967, 05/25/2022; 520221, 06/08/2022; 520387, 06/15/2022; 520388, 06/15/2022; 520563, 06/18/2022; 527137, 01/20/2023; 527205, 01/20/2023; 527402, 01/28/2023; 527497, 01/28/2023; 527576, 02/04/2023; 527642, 02/08/2023; 527844, 02/17/2023; 528024, 02/18/2023; List Number: 09N78-03E, UDI (01)00884999050211(240)09N78-03E(8012)5.oo
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Abbott Molecular, Inc.
Reason for Recall:: There is a potential for false positive results.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

Product Codes/Lot Numbers:

List Number: 09N78-090, UDI UDI 00884999049222; Lot/Serial, Expiration: 511468, 09/15/2021; 511504, 09/15/2021; 511505, 09/15/2021; 512025, 09/21/2021; 512416, 09/18/2021; 512417, 09/18/2021; 512705, 09/21/2021; 512712, 10/07/2021; 512898, 10/07/2021; 513147, 10/14/2021; 513629, 11/18/2021; 514359, 12/01/2021; 514762, 12/17/2021; 515053, 01/05/2022; 515415, 01/15/2022; 515416, 01/15/2022; 515948, 01/28/2022; 516084, 02/05/2022; 516430, 02/17/2022; 516431, 02/18/2022; 516612, 02/25/2022; 516636, 03/01/2022; 516910, 03/04/2022; 516911, 02/11/2022; 517009, 02/18/2022; 517138, 02/25/2022; 517354, 03/08/2022; 517876, 03/19/2022; 517998, 03/19/2022; 518668, 04/01/2022; 518669, 04/20/2022; 518878, 04/20/2022; 519022, 04/30/2022; 519122, 04/30/2022; 519372, 05/03/2022; 519373, 05/11/2022; 519784, 05/18/2022; 519967, 05/25/2022; 520221, 06/08/2022; 520387, 06/15/2022; 520388, 06/15/2022; 520563, 06/18/2022; 527137, 01/20/2023; 527205, 01/20/2023; 527402, 01/28/2023; 527497, 01/28/2023; 527576, 02/04/2023; 527642, 02/08/2023; 527844, 02/17/2023; 528024, 02/18/2023; List Number: 09N78-03E, UDI (01)00884999050211(240)09N78-03E(8012)5.oo

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0006-2022

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