Recall Z-1586-2016— Ab Sciex

Class II FDA medical device recall by Ab Sciex, initiated 2016-02-24, terminated 2017-02-06. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis..

Recalling firm

Ab Sciex

Classification

Class II

Status

Terminated

Initiated

2016-02-24

Terminated

2017-02-06

Firm location

Framingham, MA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.