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).
Enforcement
- Recall Number
- Z-2666-2016
- Event ID
- 74806
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Tecan US, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 31, 2016
- Initiation Date
- July 25, 2016
- Classification Date
- August 25, 2016
- Termination Date
- January 23, 2017
- Address
- 9401 Globe Center Drive, Suite 140, Morrisville, NC, 27560, United States
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).
The batteries have the potential to overheating, melt or char.
Instrument Material #30087532, PC Serial #2CE4240D4X, Instrument Serial # 1411004534.
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.
1 unit