# FDA recall Z-2649-2017

> **Medtest Holdings, Inc.** · Class III · device recall initiated 2010-11-22.

## 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

## Distribution

FL, AR, NICARAGUA, KOREA

## Key facts

- **Recall number:** Z-2649-2017
- **Recalling firm:** Medtest Holdings, Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2010-11-22
- **Report date:** 2017-07-05
- **Termination date:** 2017-07-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Canton, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2649-2017

## Citation

> AI Analytics. FDA recall Z-2649-2017. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2649-2017. Source: US FDA. Licensed CC0.

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