Z-2782-2016 Class III Terminated
FDA device recall Z-2782-2016 was initiated by Clark Laboratories, Inc. (dba,Trinity Biotech USA) on July 11, 2016 and is designated Class III. 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). The recall status is terminated (terminated May 9, 2017). Affected quantity: US: 6 kits, Foreign: 50 kits.
Recall Details
- Product Type
- Devices
- Report Date
- September 21, 2016
- Initiation Date
- July 11, 2016
- Termination Date
- May 9, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US: 6 kits, Foreign: 50 kits
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).
Distribution Pattern
Distribution to US nationwide including California, and China (Hong Kong).
Code Information
Lot Number 2326060-043, Expiration Date 31 May 2017