Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum ( the agent of syphilis). It is also intended for testing of serum or plasma specimens to screen blood and/or plasma donors to exclude a history of syphilis.

Class I - Dangerous

🏥 Medical Devices Recalled: August 27, 2013 Clark Laboratories, Inc. (dba,Trinity Biotech USA) Diagnostic Equipment Nationwide

What Should You Do?

Check if you have this product:
Product Code: 800-960, Lot number: 082, Model: 10 - plate kit
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
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:: Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum ( the agent of syphilis). It is also intended for testing of serum or plasma specimens to screen blood and/or plasma donors to exclude a history of syphilis.