CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    GTIN: 05055273201765 Batch: 588434
  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
Reason for Recall:
The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls do not show the same bias and will be within range
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826

Product Codes/Lot Numbers:

GTIN: 05055273201765 Batch: 588434

Distribution:

Distributed in: PA, OH, WV

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1286-2023

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