Device product
Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
Z-0622-2019
Product summary
- Event
- Event 81488
- Status
- Terminated
- Classification
- Class II
- Quantity
- 252 units
- Official record key
device-enforcement:Z-0622-2019
Official wording
Reason: lack of 510K
Code information: all serial numbers
Distribution pattern: IL, WV, NJ, AZ, MD, UT
Derived failure modes
-
Unknown
lack of 510K