# FDA recall Z-2650-2017

> **Medtest Holdings, Inc.** · Class III · device recall initiated 2011-10-19.

## Product

Pointe Scientific Liquid Creatine Kinase Reagent Set  Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.

## Reason for recall

Linear performance information in product insert does not match that listed in the approved premarket notification

## Distribution

Nationwide Distribution

## Key facts

- **Recall number:** Z-2650-2017
- **Recalling firm:** Medtest Holdings, Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2011-10-19
- **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-2650-2017

## Citation

> AI Analytics. FDA recall Z-2650-2017. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2650-2017. Source: US FDA. Licensed CC0.

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