Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UDI-DI/Lots: 00380740129026/000586790 and 000586879
  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 Laboratories
Reason for Recall:
Reaction vessels may contain a potential contaminant that could affect their optical performance.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels

Product Codes/Lot Numbers:

UDI-DI/Lots: 00380740129026/000586790 and 000586879

Distribution:

Distributed in: US, IL, MN, MO, NC, ND, NJ, NY, OK, SC, TX, WV

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0958-2023

Related Recalls

When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.

Mar 18, 2025 Other Medical Devices Nationwide View Details →

When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.

Mar 18, 2025 Other Medical Devices Nationwide View Details →