Device product
ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.
Z-2347-2019
Product summary
- Event
- Event 83487
- Status
- Terminated
- Classification
- Class II
- Quantity
- 46
- Official record key
device-enforcement:Z-2347-2019
Official wording
Reason: Residual crystallization of the microplate and recurrent negative controls out of range.
Code information: F1701571
Distribution pattern: Distribution to US states of NC, NH, NY, and OH, and Sweden.
Derived failure modes
-
Unknown
Residual crystallization of the microplate and recurrent negative controls out of range.