Home / Recalls / Medtest Holdings, Inc. / Z-2165-2017

Z-2165-2017 Class II Terminated

Recalled by Medtest Holdings, Inc. — Canton, MI

FDA device recall Z-2165-2017 was initiated by Medtest Holdings, Inc. on July 8, 2011 and is designated Class II. Reason for recall: Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met. The recall status is terminated (terminated June 2, 2017). Affected quantity: 716.146L total.

Recall Details

Product Type
Devices
Report Date
June 7, 2017
Initiation Date
July 8, 2011
Termination Date
June 2, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
716.146L total

Product Description

Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum.

Reason for Recall

Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met.

Distribution Pattern

Nationwide

Code Information

L7572 all configurations

Other recalls by Medtest Holdings, Inc.

  • Z-0389-2019 Class III — Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - (August 10, 2018)
  • 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-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)

FDA data resources