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Medtest Holdings Recalls
10 recalls on record · July 6, 2016 to November 14, 2018 · Medical Devices
Recalls by year
16
17
18
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 14, 2018Medical DevicesFDA
Medtest Holdings, Inc. recalls Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of P
Hazard: Vials of the autoHDL/LDL Calibrator were shipped without a vial label.
July 5, 2017Medical DevicesFDA
Medtest Holdings, Inc. recalls Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK
Hazard: Linear performance information in product insert does not match that listed in the approved premarket notification
July 5, 2017Medical DevicesFDA
Medtest Holdings, Inc. recalls The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit
Hazard: Incorrect control range in product labeling
July 5, 2017Medical DevicesFDA
Medtest Holdings, Inc. recalls Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x
Hazard: Individual vials of calibrator and standard were mislabeled; specifically the units on the vial labels are incorrectly listed as mg/dl when the correct unit is mg/L.
June 21, 2017Medical DevicesFDA
Medtest Holdings, Inc. recalls Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirub
Hazard: Decrease reactivity of R 1 component.
June 14, 2017Medical DevicesFDA
Medtest Holdings, Inc. recalls MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with
Hazard: MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) control values are outside of specification.
June 7, 2017Medical DevicesFDA
Medtest Holdings, Inc. recalls Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative
Hazard: Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met.
May 31, 2017Medical DevicesFDA
Medtest Holdings, Inc. recalls Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass
Hazard: 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.
May 24, 2017Medical DevicesFDA
Medtest Holdings, Inc. recalls Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic c
Hazard: A Discrepancy was found on Hitachi AST (HA7 61) package insert. Limitations section indicates linearity is 500 U/L and the Performance section linearity is listed as 0-600 U/L, which is not consistent with the 510k submission package insert.
July 6, 2016Medical DevicesFDA
Medtest Holdings, Inc. recalls Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in human serum
Hazard: Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery. The manufacturer has indicated that the HOMOCYSTEINE REAGENT lot listed above shows deterioration in assay performance manifesting itself by under recovery of Homocysteine in Controls and Patient Samples. The cause of this deterioration has been attributed to a loss of reductant activity in Reagent 1. Testing performed indicated that the affected lot is at the limit of acceptable clinical performance. This observation was consistent across the reportable range of the assay. For this reason, do not continue to use affected reagent lot. Test data generated to date will be acceptable where validity control specifiCations have been met.