FDAFDA · Food and drugs·Recall number Z-0819-2015
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.
Published December 24, 2014 · Recall initiated: November 17, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Clark Laboratories, Inc. (dba,Trinity Biotech USA)
- Distributor
- New York, Florida, Utah, and California plus foreign distribution to Spain and France
- Lot
- Lot 033, expiry date 30 November 2014
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.