Device product
Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) infection.
Z-1503-2021
Product summary
- Event
- Event 87637
- Status
- Terminated
- Classification
- Class II
- Quantity
- 80 kits
- Official record key
device-enforcement:Z-1503-2021
Official wording
Reason: Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting
Code information: Kit Lot: 2326060-060 Expiration Date: 2021-06-28 (UDI): 05391516743655
Distribution pattern: Worldwide distribution - US Nationwide distribution and the country of Ireland.
Derived failure modes
-
Unknown
Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting