Device product
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.
Z-0819-2015
Product summary
- Event
- Event 69827
- Status
- Terminated
- Classification
- Class III
- Quantity
- Domestic: 9 kits; Foreign: 26 kits
- Official record key
device-enforcement:Z-0819-2015
Official wording
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.
Code information: Lot 033, expiry date 30 November 2014
Distribution pattern: New York, Florida, Utah, and California plus foreign distribution to Spain and France
Derived failure modes
-
Unknown
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.