Home / Recalls / Tecan US, Inc. / Z-2665-2016

Z-2665-2016 Class II Terminated

Recalled by Tecan US, Inc. — Morrisville, NC

FDA device recall Z-2665-2016 was initiated by Tecan US, Inc. on Jul 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 Jan 23, 2017). Affected quantity: 11 units.

Recall Details

Product Type
Devices
Report Date
Aug 31, 2016
Initiation Date
Jul 25, 2016
Termination Date
Jan 23, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11 units

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.

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 #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.

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-2665-2016
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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  • Z-2666-2016 Class II — Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The… (Jul 25, 2016)
  • Z-2661-2016 Class II — SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader… (Jul 25, 2016)
  • Z-2663-2016 Class II — Infinite 200 PRO The Tecan Infinite 200 PRO is a multifunctional microplate… (Jul 25, 2016)
  • Z-1971-2015 Class II — Infinite 200 in vitro diagnostic. Product Usage: The Tecan Infinite 200… (May 29, 2015)

FDA data resources