Device 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).
Z-2666-2016
Product summary
- Firm
- Tecan US, Inc.
- Event
- Event 74806
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-2666-2016
Official wording
Reason: The batteries have the potential to overheating, melt or char.
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.
Derived failure modes
-
Unknown
The batteries have the potential to overheating, melt or char.