Medtest Holdings, Inc.
Medical device manufacturer in Canton, MI.
0510(k) clearances
0PMA approvals
10recalls
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0389-2019 Class III | Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product…Vials of the autoHDL/LDL Calibrator were shipped without a vial label. | 08/10/2018Terminated |
| Z-2063-2016 Class II | Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of…Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under… | 04/03/2015Terminated |
| Z-2316-2017 Class III | MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200…MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) control values are outside… | 10/23/2014Terminated |
| Z-2121-2017 Class III | Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white…The original mean assigned to the control too high, upon reassignment with additional data the new assigned… | 05/15/2014Terminated |
| Z-2586-2017 Class II | Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry…Decrease reactivity of R 1 component. | 03/13/2012Terminated |
| Z-2116-2017 Class III | Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE…A Discrepancy was found on Hitachi AST (HA7 61) package insert. Limitations section indicates linearity is… | 02/15/2012Terminated |
| Z-2650-2017 Class III | Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two…Linear performance information in product insert does not match that listed in the approved premarket… | 10/19/2011Terminated |
| Z-2165-2017 Class II | Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For…Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met. | 07/08/2011Terminated |
| Z-2649-2017 Class III | The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control…Incorrect control range in product labeling | 11/22/2010Terminated |
| Z-2631-2017 Class III | Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide…Individual vials of calibrator and standard were mislabeled; specifically the units on the vial labels are… | 07/21/2009Terminated |