Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
FDA device recall Z-2782-2016 · posted 2016-09-12 · Terminated
Recall details
- Recalling firm
- Clark Laboratories, Inc. (dba,Trinity Biotech USA)
- 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).
- Action taken
- Recall notification letters (dated 7/11/2016) were sent by FedEx on 7/11/2016. Customers were instructed to discontinue use of any remaining inventory (discard on site if any remaining). Customers were also advised that if the test resulted in a valid run, such that all Controls and Calibrator met the Quality Control Criteria as stated in the package insert, the patient results can be reported and a re-evaluation of patient results is not necessary. For questions, please contact Trinity Biotech's Help Desk at 1-800-325-3424 Option #3.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- PCL
- Quantity affected
- US: 6 kits, Foreign: 50 kits
- Distribution
- Distribution to US nationwide including California, and China (Hong Kong).
- Date initiated
- 2016-07-11
- Date posted
- 2016-09-12
- Date terminated
- 2017-05-09
- Location
- Jamestown, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CAPTIA MEASLES IGM (K140455) | Trinity Biotech USA | 2014-05-22 |