Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well Recalled by Tecan US, Inc. Due to The batteries have the potential to overheating, melt...

Date: July 25, 2016
Company: Tecan US, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Tecan US, Inc. directly.

Affected Products

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).

Quantity: 1 unit

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 18 states: AL, AK, AR, CA, FL, GA, HI, KY, MD, MA, NY, NC, PA, SC, TN, TX, UT, VA

Affected (18 states)Not affected

About Tecan US, Inc.

Tecan US, Inc. has 19 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report