Device product
G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes
Z-1255-2019
Product summary
- Event
- Event 82550
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 kits
- Official record key
device-enforcement:Z-1255-2019
Official wording
Reason: The target values and ranges in these lots are incorrect.
Code information: Lot Numbers: 676PD 701PD 716PD
Distribution pattern: The products were distributed to the following US states: IL, OH, NC, PA, WI, WV and Puerto Rico.
Derived failure modes
-
Unknown
The target values and ranges in these lots are incorrect.