Manufacturer

Medtest Holdings, Inc.

10 recalls in our database name Medtest Holdings, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 10
Critical: 0
Severe: 0
Most recent: 2018-11-14

Of the 10 recalls from Medtest Holdings, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–10 of 10

LowFDA (Devices)·Z-0389-2019·2018-11-14
Medtest AutoHDL/LDL Cholesterol Calibrator Recalled for Missing Vial Labels
Medtest Holdings is recalling 22 vials of AutoHDL/LDL Cholesterol Calibrator shipped without labels in five states.
Product
Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific s autoHDL and autoLDL Cholesterol Reagent Set in serum or plasma. For in vitro diagnostic use only.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2650-2017·2017-07-05
Medtest Liquid Creatine Kinase Reagent Set Recalled for Labeling Mismatch
Medtest Holdings is recalling Pointe Scientific Liquid Creatine Kinase Reagent Sets because the product insert does not match the approved premarket notification.
Product
Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2631-2017·2017-07-05
Medtest CRP Calibrator and Standard Sets Recalled for Unit Mislabeling
Medtest Holdings is recalling Pointe Scientific CRP calibrator and standard sets because vial labels incorrectly list units as mg/dl instead of mg/L.
Product
Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator Set is intended to be used for the calibration of the manuf
Category
Medical Device
Distribution
9 states
LowFDA (Devices)·Z-2649-2017·2017-07-05
Medtest Holdings Recalls CK-MB Control Kits Due to Labeling Error
Medtest Holdings is recalling five CK-MB Isoenzyme Control Kits because the product labeling contains an incorrect control range.
Product
The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-2586-2017·2017-06-21
Medtest Recalls Pointe Scientific Hitachi Total Bilirubin R1 Reagent
Medtest Holdings is recalling specific lots of Pointe Scientific Hitachi Total Bilirubin R1 Reagent due to decreased reactivity of the R1 component.
Product
Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is used with Hitachi Total Bilirubin R2 Reagent for the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro
Category
Medical Device
Distribution
11 states
LowFDA (Devices)·Z-2316-2017·2017-06-14
MedTest DX Assayed Human Multi Sera Control Recall for Out-of-Spec Values
Medtest Holdings, Inc. is recalling MedTest DX Assayed Human Multi Sera Control Level 1 and Level 2 because control values are outside of specification.
Product
MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with rubber stopper and black plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. HNC200 " Sml amber glass vials with rubber stopper and green p
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2165-2017·2017-06-07
Pointe Scientific Lactate Dehydrogenase Reagent Set Recalled for Stability Issues
Medtest Holdings is recalling Pointe Scientific Lactate Dehydrogenase Reagent Sets because the product's stability claim is not being met.
Product
Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2121-2017·2017-05-31
Medtest Recalls Pointe Scientific Chemistry Controls Due to Mean Assignment Error
Medtest Holdings is recalling Pointe Scientific Chemistry Controls Level I and II because the original mean assigned to the controls was too high, resulting in a new assigned mean outside the published range.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2116-2017·2017-05-24
Medtest Holdings Recalls Pointe Scientific Hitachi AST Reagent Due to Labeling Discrepancy
Medtest Holdings is recalling Pointe Scientific Hitachi AST Reagent because the package insert contains inconsistent linearity values in different sections.
Product
Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap. Product Usage: Two Part Chemistry Reagent For the quantitative determination of Aspartate Aminotransferase (ASl) in human serum on Hitachi analyzers.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2063-2016·2016-07-06
Medtest Homocysteine Reagent Recalled for Performance Deterioration
Medtest Holdings is recalling 13 kits of Liquid Stable 2-Part Homocysteine Reagent due to under-recovery of homocysteine in patient samples.
Product
Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in human serum and plasma - H7575-57 kit includes one Rl and one R2 bottle and one bottle of calibrator level 1 and one bottle of calibrator level 2.
Category
Medical Device
Distribution
5 states