Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    GTIN: 05055273207439 (1) Batch 600957 Lot 1378CY - 1382CY (2) Batch 621809, 621815 Lot 1403CY - 1407CY (3) Batch 650533 Lot 1414CY - 1418CY
  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:
Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699

Product Codes/Lot Numbers:

GTIN: 05055273207439 (1) Batch 600957 Lot 1378CY - 1382CY (2) Batch 621809, 621815 Lot 1403CY - 1407CY (3) Batch 650533 Lot 1414CY - 1418CY

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1369-2024

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