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U.S. Department of Health and Human Services

Enforcement Report - Week of January 1, 2014

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Event Detail

Event ID 66916
Product Type Devices
Status Ongoing
Recalling Firm Clark Laboratories, Inc. (dba,Trinity Biotech USA)
City Jamestown
State NY
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-27
Initial Firm Notification of
Consignee or Public
Distribution Pattern USA Nationwide Distribution in the state of WA

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Product Code: 800-960, Lot number: 082, Model: 10 - plate kit Class II Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results. 38 kits Z-0572-2014