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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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
Related recalls
Same manufacturer · Medtest Holdings, Inc.
See all →- LowMedtest CRP Calibrator and Standard Sets Recalled for Unit Mislabeling
FDA (Devices) · 2017-07-05
- LowMedtest Liquid Creatine Kinase Reagent Set Recalled for Labeling Mismatch
FDA (Devices) · 2017-07-05
- LowMedtest Holdings Recalls CK-MB Control Kits Due to Labeling Error
FDA (Devices) · 2017-07-05
- ModerateMedtest Recalls Pointe Scientific Hitachi Total Bilirubin R1 Reagent
FDA (Devices) · 2017-06-21
- LowMedTest DX Assayed Human Multi Sera Control Recall for Out-of-Spec Values
FDA (Devices) · 2017-06-14
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
Similar recalls
- ModerateFujifilm Recalls Wako HDL-C/LDL-C Calibrator Due to Labeling Error
FDA (Devices) · 2021-02-03
- LowMedtest CRP Calibrator and Standard Sets Recalled for Unit Mislabeling
FDA (Devices) · 2017-07-05
- LowAlere Cholestech LDX Calibration Verification Recall for HDL Errors
FDA (Devices) · 2013-02-06
- LowAlere Cholestech LDX Multianalyte Control Recalled for HDL Errors
FDA (Devices) · 2013-02-06
- LowMedtest Recalls Pointe Scientific Chemistry Controls Due to Mean Assignment Error
FDA (Devices) · 2017-05-31
- ModerateOrtho-Clinical VITROS dLDL Reagent Recalled for Negatively Biased Results
FDA (Devices) · 2018-11-28