FDA-Device2014-12-24Class III
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.
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Hazard
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.
Sold states
New York, Florida, Utah, and California plus foreign distribution to Spain and France
Affected count
Domestic: 9 kits; Foreign: 26 kits
Manufactured in
2823 Girts Rd, N/A, Jamestown, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0819-2015Don't want to check this manually?
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