Device product
Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vial w/PP black plastic cap.
Z-2121-2017
Product summary
- Event
- Event 77083
- Status
- Terminated
- Classification
- Class III
- Quantity
- 132919 Vol vials
- Official record key
device-enforcement:Z-2121-2017
Official wording
Reason: The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range.
Code information: Model Number(s): C7590-50 (Chemistry Control Level I), C7591-50 (Chemistry Control Level II), and C7592-100 (Chemistry Control Level I and II).
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range.