Recall Z-0819-2015 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
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.
| Date | Dec 16, 2014 (initiated Nov 17, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by 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. |
| Quantity | Domestic: 9 kits; Foreign: 26 kits |
| Distribution | New York, Florida, Utah, and California plus foreign distribution to Spain and France |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K904524 | CAPTIA(R) SYPHILIS M, MODIFICATION Mercia Diagnostics , Ltd., Dec 26, 1990 |