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Tecan US, Inc. recalls Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The instrument is intended to be used primaril
Recalled August 31, 2016 · FDA recall Z-2666-2016 · Tecan US
Hazard
The batteries have the potential to overheating, melt or char. · FDA Class II
Units
1 unit
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
Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The instrument is intended to be used primarily in in-vitro diagnostic processing of samples from the human body to obtain information on physiological and pathological states. Software and instrument have been validated for processing of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) and therefore are intended for professional use in in-vitro diagnostics. The instrument has not been validated for other areas of application not mentioned in the Intended Use (e.g. veterinary, biopharma).
Manufacturer(s)
Tecan US, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →