Recall Register

Food, drugs, devices › Firms

AB SCIEX

FDA recalling firm · 5 enforcement events · 8 product records · 2014–2021 · MA, N/A

AB SCIEX has 5 FDA enforcement events on this register (8 product records) between 2014 and 2021: 5 device; the busiest year was 2016 with 3.

0% of its events are Class I; the most common class is Class II (5). 0 events are listed as ongoing; the recalling firm's address is in MA and N/A.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
4 Oct 2021Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems. Model No. 5088288DeviceClass II1Terminated
16 Jun 2016AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Number (REF): 5024501 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the…DeviceClass II4Terminated
25 Mar 2016AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, Part No. 5031231. Mass spectrometers for in vitro diagnostic use only.DeviceClass II1Terminated
24 Feb 2016Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/MS System, Instrument Part Number: 5024501; 3200MD QTRAP¿ LC/MS/MS System, Instrument Part Number: 5024500; Triple Quad" 4500MD LC/MS/MS System, Instrument Part Number: 5031257; QTRAP¿ 4500MD LC/MS/MS System,…DeviceClass II1Terminated
15 Jul 2014AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens Part Number 5024543.DeviceClass II1Terminated

By type and class

Device5
Class II5

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

14
16
18
20
22
24
26
Enforcement events for AB SCIEX by year initiated.

Questions and answers

How many FDA recalls has AB SCIEX had?

5 enforcement events (8 product records) on this register, 2014–2021: 5 device.

Are any AB SCIEX recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are AB SCIEX recalls?

5 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.