Device product
Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum.
Z-2165-2017
Product summary
- Event
- Event 77048
- Status
- Terminated
- Classification
- Class II
- Quantity
- 716.146L total
- Official record key
device-enforcement:Z-2165-2017
Official wording
Reason: Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met.
Code information: L7572 all configurations
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met.