Medtest Holdings, Inc.
Complete recall history across all FDA and CPSC categories — 10 total recalls
Medtest Holdings, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (10)
FDA medical device enforcement actions by Medtest Holdings, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Aug 10, 2018 | Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CA... | Vials of the autoHDL/LDL Calibrator were shipped without a vial label. | Class III |
| Apr 3, 2015 | Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determin... | Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE RE... | Class II |
| Oct 23, 2014 | MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC... | MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HE... | Class III |
| May 15, 2014 | Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial... | The original mean assigned to the control too high, upon reassignment with ad... | Class III |
| Mar 13, 2012 | Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two p... | Decrease reactivity of R 1 component. | Class II |
| Feb 15, 2012 | Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic ... | A Discrepancy was found on Hitachi AST (HA7 61) package insert. Limitations ... | Class III |
| Oct 19, 2011 | Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit compris... | Linear performance information in product insert does not match that listed i... | Class III |
| Jul 8, 2011 | Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s... | Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim ... | Class II |
| Nov 22, 2010 | The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level ... | Incorrect control range in product labeling | Class III |
| Jul 21, 2009 | Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(H... | Individual vials of calibrator and standard were mislabeled; specifically the... | Class III |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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