AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125; AutoMate 2500 Catalog Number ODL25250; AutoMate 2550 Catalog Number ODL25255

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    All systems up to the following Serial Numbers: ODL25120 Revision T; SN3101, ODL25125 Revision W; SN1508, ODL25250 Revision T; SN2416, ODL25255 Revision W; SN4617
  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:
Beckman Coulter Inc.
Reason for Recall:
Belts on the x-axis (and on the y-axis, to a lesser extent) manufactured from 2015 are showing premature failure, posing the remote risk of cross-contamination.
Classification:
Class I - Dangerous

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

Status:
completed

Product Information

Full Description:

AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125; AutoMate 2500 Catalog Number ODL25250; AutoMate 2550 Catalog Number ODL25255

Product Codes/Lot Numbers:

All systems up to the following Serial Numbers: ODL25120 Revision T; SN3101, ODL25125 Revision W; SN1508, ODL25250 Revision T; SN2416, ODL25255 Revision W; SN4617

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1169-2018

Related Recalls

Class I - Dangerous

Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. For a pregnant patient being monitored for thyroid hormone supplementation, incorrect treatment or dose may be used. A delayed patient results could cause repeat blood draw with associated complications.

Mar 16, 2026 Other Medical Devices Nationwide View Details →

Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.

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