The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit
FDA device recall Z-2649-2017 · posted 2017-06-29 · Terminated
Recall details
- Recalling firm
- Medtest Holdings, Inc.
- Reason for recall
- Incorrect control range in product labeling
- Action taken
- On 11/22/2010, TECHNICAL BULLETIN notifications were sent to the affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, and consignee responsibilities.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- JHW
- Quantity affected
- 5 kits
- Distribution
- FL, AR, NICARAGUA, KOREA
- Date initiated
- 2010-11-22
- Date posted
- 2017-06-29
- Date terminated
- 2017-07-24
- Location
- Canton, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CREATINE KINASE MB DETERMINATION (UV) (K942958) | Biochemical Trade, Inc. | 1994-11-21 |