The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB… — Class III medical device recall Z-2649-2017
Terminated recall by Medtest Holdings, Inc., reported 2017-07-05, distributed in AR, FL. Incorrect control range in product labeling
| Recall number | Z-2649-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtest Holdings, Inc., Canton, MI, United States |
| Recall initiated | 2010-11-22 |
| Classified | 2017-06-29 |
| Reported by FDA | 2017-07-05 |
| Terminated | 2017-07-24 |
| Distributed | AR, FL |
| Countries outside the US | KR, NI |
| Quantity | 5 kits |
| Reason classes | labeling |
| Lot numbers | 013206-260, 2013-03 |
| Model numbers | C7562-12 |
Product
The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit
Reason for recall
Incorrect control range in product labeling
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2649-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.