Ab Sciex recalls Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/MS System, Instrumen

Recalled May 11, 2016 · FDA recall Z-1586-2016 · Ab Sciex

Hazard

Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis. · FDA Class II

Units

279

Sold at

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

Description

Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis.

Product

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(s)

Ab Sciex

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →