🔍 RecallPedia

SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825

Class I - Dangerous
🏥 Medical Devices Recalled: November 10, 2021 Beckman Coulter Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot: M106450, UDI: 15099590575113
  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:
Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low quality control recovery failures may be observed after passing calibration. Brown particulates in compartment C of the reagent cartridge may be observed. Continued use may lead to, 1) failed QC and/or calibrations, 2) Erroneous low Cholesterol patient results.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825

Product Codes/Lot Numbers:

Lot: M106450, UDI: 15099590575113

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0399-2022

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