Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
This recall has been terminated (originally issued September 12, 2016).
- Recall Initiated
- July 11, 2016
- Posted
- September 12, 2016
- Terminated
- May 9, 2017
- Recall Number
- Z-2782-2016
- Quantity
- US: 6 kits, Foreign: 50 kits
- Firm Location
- Jamestown, NY
- Official Source
- View on FDA website ↗
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).
Distribution
Distribution to US nationwide including California, and China (Hong Kong).
Lot / Code Info
Lot Number 2326060-043, Expiration Date 31 May 2017
Root Cause
Nonconforming Material/Component
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.