Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    All lots.
  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:
The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls increase over the shelf life of the product. This may lead to a delay in reporting Free Kappa Light Chains results, which are used as an aid in diagnosis of monoclonal gammopathy of undetermined significance and for Multiple Myeloma through review of the ratio with free lambda chains.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682

Product Codes/Lot Numbers:

All lots.

Distribution:

Distributed in: CA, IN, KS, ME, WV, PR

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2278-2018

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