# FDA recall Z-0389-2019

> **Medtest Holdings, Inc.** · Class III · device recall initiated 2018-08-10.

## Product

Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific s autoHDL and autoLDL Cholesterol Reagent Set in serum or plasma. For in vitro diagnostic use only.

## Reason for recall

Vials of the autoHDL/LDL Calibrator were shipped without a vial label.

## Distribution

US Nationwide in the states of CA, FL, GA, MI, and OH.

## Key facts

- **Recall number:** Z-0389-2019
- **Recalling firm:** Medtest Holdings, Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-10
- **Report date:** 2018-11-14
- **Termination date:** 2019-12-04

- **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-0389-2019

## Citation

> AI Analytics. FDA recall Z-0389-2019. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0389-2019. Source: US FDA. Licensed CC0.

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