Tecan US, Inc. recalls Tecan Infinite 200. The SUNRISE instrument is a 96-well absorbance reader for the measurement of light absorbance (opti

Recalled August 31, 2016 · FDA recall Z-2662-2016 · Tecan US

Hazard

The batteries have the potential to overheating, melt or char. · FDA Class II

Units

5 units

Sold at

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.

Description

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

Product

Tecan Infinite 200. The SUNRISE instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and instrument specifications; they are therefore for professional use in in-vitro diagnostics.

Manufacturer(s)

Tecan US, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →