🔍 RecallPedia

Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

Class I - Dangerous
🏥 Medical Devices Recalled: September 2, 2021 Abbott Molecular Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    List Number: 09N79-096, UDI 00884999049390 Lot/Serial, Expiration: 513424, 10/13/2021; 513771, 10/13/2021; 513861, 11/06/2021; 514503, 11/19/2021; 515652, 12/02/2021; 516411, 11/06/2021; 517877, 12/02/2021; 518436, 12/10/2021; 518877, 12/10/2021; 519091, 11/06/2021; 519243, 05/10/2022; 519582, 05/10/2022; 519969, 05/10/2022; 520356, 05/10/2022; 520695, 07/08/2022; 522088, 08/04/2022; 522128, 08/26/2022; 523152, 10/10/2022; 524433, 01/15/2023; 526710, 01/21/2023; 527845, 02/08/2023; List Number 09N79-05D, UDI (01) 00884999050242(240 )09N79-05D(8012)4.oo
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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 Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

Product Codes/Lot Numbers:

List Number: 09N79-096, UDI 00884999049390 Lot/Serial, Expiration: 513424, 10/13/2021; 513771, 10/13/2021; 513861, 11/06/2021; 514503, 11/19/2021; 515652, 12/02/2021; 516411, 11/06/2021; 517877, 12/02/2021; 518436, 12/10/2021; 518877, 12/10/2021; 519091, 11/06/2021; 519243, 05/10/2022; 519582, 05/10/2022; 519969, 05/10/2022; 520356, 05/10/2022; 520695, 07/08/2022; 522088, 08/04/2022; 522128, 08/26/2022; 523152, 10/10/2022; 524433, 01/15/2023; 526710, 01/21/2023; 527845, 02/08/2023; List Number 09N79-05D, UDI (01) 00884999050242(240 )09N79-05D(8012)4.oo

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0008-2022

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