Home / Recalls / Medtest Holdings, Inc. / Z-0389-2019

Z-0389-2019 Class III Terminated

Recalled by Medtest Holdings, Inc. — Canton, MI

Recall Details

Product Type
Devices
Report Date
November 14, 2018
Initiation Date
August 10, 2018
Termination Date
December 4, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
22

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.

Reason for Recall

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

Distribution Pattern

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

Code Information

Lot Number 808801-180; UDI: 00811727011411

Other recalls by Medtest Holdings, Inc.

  • Z-2063-2016 Class II — Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determinati (April 3, 2015)
  • Z-2316-2017 Class III — MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200 (October 23, 2014)
  • Z-2121-2017 Class III — Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/ (May 15, 2014)
  • Z-2586-2017 Class II — Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part (March 13, 2012)
  • Z-2116-2017 Class III — Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap (February 15, 2012)
  • Z-2650-2017 Class III — Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised (October 19, 2011)
  • Z-2165-2017 Class II — Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): (July 8, 2011)
  • Z-2649-2017 Class III — The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II (November 22, 2010)
  • Z-2631-2017 Class III — Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) (July 21, 2009)