Medtest Holdings, Inc.

FDA Regulatory Profile

Summary

Total Recalls
10
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0389-2019Class IIIPointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For August 10, 2018
Z-2063-2016Class IILiquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocystApril 3, 2015
Z-2316-2017Class IIIMedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml aOctober 23, 2014
Z-2121-2017Class IIIPointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic capMay 15, 2014
Z-2586-2017Class IIPointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent HMarch 13, 2012
Z-2116-2017Class IIIPointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic boFebruary 15, 2012
Z-2650-2017Class IIIPointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an ROctober 19, 2011
Z-2165-2017Class IIPointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the inJuly 8, 2011
Z-2649-2017Class IIIThe Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 CNovember 22, 2010
Z-2631-2017Class IIIPointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard July 21, 2009