🔍 RecallPedia

Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.

Class I - Dangerous
🏥 Medical Devices Recalled: May 29, 2012 Clark Laboratories, Inc. (dba,Trinity Biotech USA) Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Kit lot codes: 2325600-566, 2325601-566, 2325600-567, 2325601-567, 2325600-568
  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 Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR 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 VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.

Product Codes/Lot Numbers:

Kit lot codes: 2325600-566, 2325601-566, 2325600-567, 2325601-567, 2325600-568

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2445-2012

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