Recall Z-2665-2016— 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: Tecan Infinite M1000 PRO The Tecan Infinite M1000 PRO is a multifunctional monochromator-based microplate reader that provides high performance for the vast majority of todays microplate applications and research. In addition to offering absorbance and fluorescence intensity measurements, the Infinite M1000 PRO can also perform fluorescence polarization and luminescence measurements (including luminescence scans) as well as Amplified Luminescent Proximity Homogeneous Assays (AlphaScreen and AlphaLISA). The Infinite M1000 PRO is also robotic compatible and offers a built-in stacker option as well as an external injector module. The Infinite M1000 PRO is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANSI/SBS standards.. 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

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