Z-2664-2016 Class II Terminated

Recalled by Tecan US, Inc. — Morrisville, NC

FDA device recall Z-2664-2016 was initiated by Tecan US, Inc. on July 25, 2016 and is designated Class II. Reason for recall: The batteries have the potential to overheating, melt or char. The recall status is terminated (terminated January 23, 2017). Affected quantity: 1 unit.

Recall Details

Product Type
Devices
Report Date
August 31, 2016
Initiation Date
July 25, 2016
Termination Date
January 23, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit

Product Description

Tecan Infinite M1000 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 an external injector module. The Infinite M1000 is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANSI/SBS standards

Reason for Recall

The batteries have the potential to overheating, melt or char.

Distribution Pattern

Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA. International account: Canada.

Code Information

Instrument Material #30034301, PC Serial number: 2CE33625NS, Instrument Serial #1508007738.