CK MB Calibrator, Catalogue Number CK2393

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    GTIN 05055273201451 Lot 4410CK
  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:
Randox Laboratories Ltd.
Reason for Recall:
Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value will cause a positive shift of approximately 6% with both Quality Controls and Patient Samples.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

CK MB Calibrator, Catalogue Number CK2393

Product Codes/Lot Numbers:

GTIN 05055273201451 Lot 4410CK

Distribution:

Distributed in: WV, PR, UK

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1097-2022

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