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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