Medtest Holdings, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0389-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product 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 Classification:

Class III

Date Initiated: August 10, 2018

Date Posted: November 14, 2018

Recall Number: Z-0389-2019

Event ID: 81160

Reason for Recall:

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

Status: Terminated

Product Quantity: 22

Code Information:

Lot Number 808801-180; UDI: 00811727011411

Distribution Pattern:

US Nationwide in the states of CA, FL, GA, MI, and OH.

Voluntary or Mandated:

Voluntary: Firm initiated