Device product
The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit
Z-2649-2017
Product summary
- Event
- Event 77453
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5 kits
- Official record key
device-enforcement:Z-2649-2017
Official wording
Reason: Incorrect control range in product labeling
Code information: Model C7562-12 Control Kit. Lot: 013206-260, Expiration Date: 2013-03
Distribution pattern: FL, AR, NICARAGUA, KOREA
Derived failure modes
-
Unknown
Incorrect control range in product labeling