Home / Recalls / Medtest Holdings, Inc. / Z-2649-2017

Z-2649-2017 Class III Terminated

Recalled by Medtest Holdings, Inc. — Canton, MI

Recall Details

Product Type
Devices
Report Date
July 5, 2017
Initiation Date
November 22, 2010
Termination Date
July 24, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5 kits

Product Description

The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit

Reason for Recall

Incorrect control range in product labeling

Distribution Pattern

FL, AR, NICARAGUA, KOREA

Code Information

Model C7562-12 Control Kit. Lot: 013206-260, Expiration Date: 2013-03

Other recalls by Medtest Holdings, Inc.

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  • 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-2631-2017 Class III — Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) (July 21, 2009)