MicroScan Neg MIC 3J REF C54814

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Catalog Number: C54814 UDI code: N/A Lot Number: 2025-08-23
  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:
Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

MicroScan Neg MIC 3J REF C54814

Product Codes/Lot Numbers:

Catalog Number: C54814 UDI code: N/A Lot Number: 2025-08-23

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1772-2026

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.

Nov 10, 2025 Other Medical Devices Nationwide View Details →

Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.

Nov 26, 2025 Other Medical Devices Nationwide View Details →