Medtest AutoHDL/LDL Cholesterol Calibrator Recalled for Missing Vial Labels
Medtest Holdings is recalling 22 vials of AutoHDL/LDL Cholesterol Calibrator shipped without labels in five states.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a packaging/labeling defect (missing vial label) rather than a contamination or functional failure.
Plain-English summary
Medtest Holdings, Inc. is recalling 22 vials of Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL. The product is used for the calibration of Pointe Scientific's autoHDL and autoLDL Cholesterol Reagent Set in serum or plasma for in vitro diagnostic use only.
The recall was initiated because the vials were shipped without a vial label. The affected units are identified by Lot Number 808801-180 and UDI 00811727011411.
The product was distributed nationwide in the states of California, Florida, Georgia, Michigan, and Ohio. Users should stop using the product and contact Medtest Holdings for further instructions.
The recalled product
- 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.
- Manufacturer
- Medtest Holdings, Inc.
- Hazard
- Affected units
- 22
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Number 808801-180
- UDI: 00811727011411
Distribution
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