Ab Sciex
Complete recall history across all FDA and CPSC categories — 8 total recalls
Ab Sciex 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 (8)
FDA medical device enforcement actions by Ab Sciex
| Date | Product | Reason | Class |
|---|---|---|---|
| Oct 4, 2021 | Cliquid MD version 3.4 software used in conjunction with Analyst MD software ... | The values of the Internal Standard (IS) concentrations are incorrectly deriv... | Class II |
| Jun 16, 2016 | AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for In-Vitro... | MultiQuant MD software where under certain conditions a user can be presente... | Class II |
| Jun 16, 2016 | AB SCIEX 3200MD QTRAP¿ LC/MS/MS System Mass Spectrometer for In-Vitro Diagn... | MultiQuant MD software where under certain conditions a user can be presente... | Class II |
| Jun 16, 2016 | AB SCIEX QTRAP¿ 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagn... | MultiQuant MD software where under certain conditions a user can be presente... | Class II |
| Jun 16, 2016 | AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Nu... | MultiQuant MD software where under certain conditions a user can be presente... | Class II |
| Mar 25, 2016 | AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500... | Under certain conditions, mass spectrometers may report incorrect quantitativ... | Class II |
| Feb 24, 2016 | Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instrume... | Wrong quantitative results may be displayed in a report from the device, whic... | Class II |
| Jul 15, 2014 | AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vit... | Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software ... | Class II |
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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