Tecan US, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2666-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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).

Product Classification:

Class II

Date Initiated: July 25, 2016

Date Posted: August 31, 2016

Recall Number: Z-2666-2016

Event ID: 74806

Reason for Recall:

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

Status: Terminated

Product Quantity: 1 unit

Code Information:

Instrument Material #30087532, PC Serial #2CE4240D4X, Instrument Serial # 1411004534.

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.

Voluntary or Mandated:

Voluntary: Firm initiated