Recall Z-2649-2017 ยท JHW U.V. Method, Cpk Isoenzymes
Medtest Holdings, Inc.
The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit
| Date | Jun 29, 2017 (initiated Nov 22, 2010) |
| Status | Terminated |
| Reason | Incorrect control range in product labeling |
| Root cause | Employee error |
| Action | 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. |
| Quantity | 5 kits |
| Distribution | FL, AR, NICARAGUA, KOREA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K942958 | CREATINE KINASE MB DETERMINATION (UV) Biochemical Trade, Inc., Nov 21, 1994 |