🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: August 10, 2018 Medtest Holdings Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Number 808801-180; UDI: 00811727011411
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Medtest Holdings, Inc.
Reason for Recall:
Vials of the autoHDL/LDL Calibrator were shipped without a vial label.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

Lot Number 808801-180; UDI: 00811727011411

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0389-2019

Related Recalls

Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator Set is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only. The Pointe Scientific CRP (HS) Wide Range Multi-Standard Set Is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only

Medtest Holdings

Class I - Dangerous

Individual vials of calibrator and standard were mislabeled; specifically the units on the vial labels are incorrectly listed as mg/dl when the correct unit is mg/L.

Jul 21, 2009 Diagnostic Equipment View Details →