Z-0819-2015 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 24, 2014
- Initiation Date
- November 17, 2014
- Termination Date
- May 24, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Domestic: 9 kits; Foreign: 26 kits
Product 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.
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.
Distribution Pattern
New York, Florida, Utah, and California plus foreign distribution to Spain and France
Code Information
Lot 033, expiry date 30 November 2014