Home / Recalls / Medtest Holdings, Inc. / Z-2650-2017

Z-2650-2017 Class III Terminated

Recalled by Medtest Holdings, Inc. — Canton, MI

FDA device recall Z-2650-2017 was initiated by Medtest Holdings, Inc. on October 19, 2011 and is designated Class III. Reason for recall: Linear performance information in product insert does not match that listed in the approved premarket notification The recall status is terminated (terminated July 24, 2017). Affected quantity: 319.922 L.

Recall Details

Product Type
Devices
Report Date
July 5, 2017
Initiation Date
October 19, 2011
Termination Date
July 24, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
319.922 L

Product Description

Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.

Reason for Recall

Linear performance information in product insert does not match that listed in the approved premarket notification

Distribution Pattern

Nationwide Distribution

Code Information

Models: C7522, HC422, HC722, HC922. Lot#'s: 020902; 029902 R1; 029902 R2; 029903; 113204; 129403; 209001. Exp dates 7/2012 to 9/2013.

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-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)

FDA data resources