FDA Device recall Z-2649-2017
The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit
- FDA Device
- Class III
- terminated
- Published 2017-07-05
On 2017-07-05 the FDA classified a Class III recall of The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit by Medtest Holdings, citing incorrect control range in product labeling.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2649-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2010-11-22 |
| Published | 2017-07-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtest Holdings |
| Distribution | AR, FL |
Product
The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit
Reason
Incorrect control range in product labeling
Identifiers
| code_info | Model C7562-12 Control Kit. Lot: 013206-260, Expiration Date: 2013-03 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2649-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.