Tecan US product recalled over fire hazard

Recall date

July 25, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Tecan US, Inc. recalls Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The instrument is intended to be used primaril…

Recall number

Z-2666-2016

FDA classification

Class II

Brand / firm

Tecan US, Inc.

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).