Recall Z-0819-2015— Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Class III · Terminated
Class III FDA medical device recall by Clark Laboratories, Inc. (dba,Trinity Biotech USA), initiated 2014-11-17, terminated 2016-05-24. It names one FDA 510(k) clearance: K904524. 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.. 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..
- Recalling firm
- Clark Laboratories, Inc. (dba,Trinity Biotech USA)
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2014-11-17
- Terminated
- 2016-05-24
- Firm location
- Jamestown, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.