Devices

Device Recall AB Sciex API 3200MD, 3200MD QTRAP, Triple Quad, QTRAP 4500MD LC/MS/MS Systems

Model / Serial
Software Versions: Version 1.6.1 and 1.6.2
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - US (Nationwide) and Internationally to the following countries: AUSTRIA CANADA CHINA FRANCE GERMANY INDIA IRELAND ITALY KOREA MALAYSIA NETHERLANDS NORWAY RUSSIA SINGAPORE SPAIN SWITZERLAND UNITED KINGDOM
Product Description
Analyst¿ 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, Instrument Part Number: 5031231 || 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 resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.
Manufacturer
Ab Sciex
1 Event
- Recall of Device Recall AB Sciex API 3200MD, 3200MD QTRAP, Triple Quad, QTRAP 4500MD LC/MS/MS Systems

Manufacturer

Ab Sciex

Manufacturer Address
Ab Sciex, 500 Old Connecticut Path, Framingham MA 01701-4574
Manufacturer Parent Company (2017)
Danaher Corporation
Source
USFDA

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