Recall Z-1969-2015— Tecan US, Inc.

Class II FDA medical device recall by Tecan US, Inc., initiated 2015-05-29, terminated 2017-08-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Infinite M1000 in vitro diagnostic. Product Usage: The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. Besides offering absorbance and fluorescence intensity measurements, the Infinite M1000 allows the measurement of fluorescence polarization and luminescence. The Infinite M1000 is also robotic compatible and offers a built-in stacker option as well as a external injector module. The Infinite M1000 is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANS/SBS standards.. Reason: A firmware bug causes incorrect values to be displayed for specific measured luminescence values..

Recalling firm

Tecan US, Inc.

Classification

Class II

Status

Terminated

Initiated

2015-05-29

Terminated

2017-08-18

Firm location

Morrisville, NC, United States

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