Home / Recalls / Medtest Holdings, Inc. / Z-2121-2017

Z-2121-2017 Class III Terminated

Recalled by Medtest Holdings, Inc. — Canton, MI

FDA device recall Z-2121-2017 was initiated by Medtest Holdings, Inc. on May 15, 2014 and is designated Class III. Reason for recall: The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range. The recall status is terminated (terminated June 2, 2017). Affected quantity: 132919 Vol vials.

Recall Details

Product Type
Devices
Report Date
May 31, 2017
Initiation Date
May 15, 2014
Termination Date
June 2, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
132919 Vol vials

Product Description

Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vial w/PP black plastic cap.

Reason for Recall

The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range.

Distribution Pattern

Nationwide

Code Information

Model Number(s): C7590-50 (Chemistry Control Level I), C7591-50 (Chemistry Control Level II), and C7592-100 (Chemistry Control Level I and II).

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-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)

FDA data resources