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.
FDA Recall Z-0819-2015 · Posted 2014-12-16
Recalling FirmClark Laboratories, Inc. (dba,Trinity Biotech USA)
Recall StatusTerminated
Product CodeLIP
Date Initiated2014-11-17
Date Terminated2016-05-24
Product QuantityDomestic: 9 kits; Foreign: 26 kits
Reason for Recall
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.
Firm Action
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.
Root Cause
Under Investigation by firm
Distribution Pattern
New York, Florida, Utah, and California plus foreign distribution to Spain and France
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.