Recall Z-2661-2016— Tecan US, Inc.

Class II FDA medical device recall by Tecan US, Inc., initiated 2016-07-25, terminated 2017-01-23. FDA's recall record names no specific 510(k) clearance for this event. Product: SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and instrument specifications; they are therefore for professional use in in-vitro diagnostics. Reason: The batteries have the potential to overheating, melt or char..

Recalling firm

Tecan US, Inc.

Classification

Class II

Status

Terminated

Initiated

2016-07-25

Terminated

2017-01-23

Firm location

Morrisville, NC, United States

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