Canton, MI, United States
Medtest Holdings, Inc. recalls
1 recall recorded since 2018, most recently on 10 August 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class III Medical devices
- Recall started
- 10 August 2018
- Terminated
- 4 December 2019
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0389-2019
- 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 diag
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.