# FDA recall Z-2631-2017

> **Medtest Holdings, Inc.** · Class III · device recall initiated 2009-07-21.

## Product

Pointe Scientific CRP(HS) Wide Range Control Set and  Pointe Scientific CRP(HS) Wide Range Standard Set  5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator Set is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only. The Pointe Scientific CRP (HS) Wide Range Multi-Standard Set Is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only

## Reason for recall

Individual vials of calibrator and standard were mislabeled; specifically the units on the vial labels are  incorrectly listed as mg/dl when the correct unit is mg/L.

## Distribution

Worldwide Distribution - US including CA, MS, NJ, PA, HI, MD, FL, OK, NV.  Foreign Distribution to CHILE

## Key facts

- **Recall number:** Z-2631-2017
- **Recalling firm:** Medtest Holdings, Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2009-07-21
- **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-2631-2017

## Citation

> AI Analytics. FDA recall Z-2631-2017. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2631-2017. Source: US FDA. Licensed CC0.

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