Tecan US, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2665-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 25, 2016

Date Posted: August 31, 2016

Recall Number: Z-2665-2016

Event ID: 74806

Reason for Recall:

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

Status: Terminated

Product Quantity: 11 units

Code Information:

Instrument Material #30063849, PC Serial # 2CE3362609, Instrument Serial #1110008219; PC Serial # CND5219H33, Instrument Serial #1204007588; PC Serial # 2CE3462FTJ, Instrument Serial #1301009861; PC Serial # 2CE3462FTD, Instrument Serial #1311007574; PC Serial #2CE33625KP, Instrument Serial #1404000703; PC Serial #2CE33625ND, Instrument Serial #1404000704; PC Serial #2CE41503PY, Instrument Serial #1406000407; PC Serial #2CE41503NW, Instrument Serial #1408001415; PC Serial #2CE41503K0, Instrument Serial #1407003406; PC Serial #CND5219GY7, Instrument Serial #1509001006 and PC Serial #CND44273YB, Instrument Serial #1604003735.

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.

Voluntary or Mandated:

Voluntary: Firm initiated