🔍 RecallPedia

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?

  1. Check if you have this product:
    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, UDI (01)00884999050211(240)09N78-03E(8012)5.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 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: 09N78-091, 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, 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-0007-2022

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