Reported Dec 24, 2014 · Terminated
Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD…
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Clark Laboratories, Inc. (dba,Trinity Biotech USA) · 2823 Girts Rd · Jamestown, NY · 14701-9666
Is this the product you have?
- 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.
- Lot codes and dates
Lot 033expiry date 30 November 2014
- Amount recalled
- Domestic: 9 kits; Foreign: 26 kits
Where it was sold
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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