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Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD

Class I - Dangerous
🏥 Medical Devices Recalled: July 11, 2016 Clark Laboratories, Inc. (dba,Trinity Biotech USA) Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Number 2326060-043, Expiration Date 31 May 2017
  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:
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Reason for Recall:
The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of range).
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD

Product Codes/Lot Numbers:

Lot Number 2326060-043, Expiration Date 31 May 2017

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2782-2016

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