Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of active syphilis in human serum.
Recall
- Recall Number
- Z-0819-2015
- Event Number
- 69827
- Firm
- Clark Laboratories, Inc. (dba, Trinity Biotech USA)
- FEI Number
- 1318354
- Product Code
- LIP
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- November 17, 2014
- Posted
- December 16, 2014
- Terminated
- May 24, 2016
- Address
- 2823 Girts Rd, Jamestown, NY, 14701-9666
Description
Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of active syphilis in human serum.
Through in-house routine real time stability monitoring of Trinity's Captia Syphilis IgM Capture Test Kit, Lot 033, the firm identified a failure of the kit to meet its labeled expiry dating of 6 months.
Recall notification letters were sent by e-mail to 2 US customers on 11/17/2014 and 11/19/2014. The remaining US customers were sent the letter by FedEx on 11/19/2014. Customers are instructed to discontinue use of any remaining inventory (discard on site if any remain) and provide date of last use (run) and if they obtained valid or invalid runs. Additionally, Trinity is in the process of sending the recall letters to the required EU Regulatory Authorities and the 3 foreign distributors.
New York, Florida, Utah, and California plus foreign distribution to Spain and France
Domestic: 9 kits; Foreign: 26 kits