Recall Z-2445-2012— 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 2012-05-29, terminated 2016-05-24. It names one FDA 510(k) clearance: K883427. Product: Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.. Reason: The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range..
- Recalling firm
- Clark Laboratories, Inc. (dba,Trinity Biotech USA)
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2012-05-29
- 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 VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.
Reason for recall
The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range.
Data sourced from openFDA. This site is unofficial and independent of the FDA.