Recall Z-2782-2016— 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 2016-07-11, terminated 2017-05-09. It names one FDA 510(k) clearance: K140455. Product: Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD. Reason: The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of range)..
- Recalling firm
- Clark Laboratories, Inc. (dba,Trinity Biotech USA)
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2016-07-11
- Terminated
- 2017-05-09
- 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 Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
Reason for recall
The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of range).
Data sourced from openFDA. This site is unofficial and independent of the FDA.