Medical device recalls

Medtest Holdings, Inc. recalls Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of…

Recall date
August 10, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0389-2019
FDA classification
Class III
Brand / firm
Medtest Holdings, Inc.
Sold / distributed
US Nationwide in the states of CA, FL, GA, MI, and OH.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.

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