Devices

Device Recall Hydroflex ELISA

Model / Serial
Instrument Material #30087532, PC Serial #2CE4240D4X, Instrument Serial # 1411004534.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
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.
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).
Manufacturer
Tecan US, Inc.
1 Event
- Recall of Device Recall Hydroflex ELISA

Manufacturer

Tecan US, Inc.

Manufacturer Address
Tecan US, Inc., 9401 Globe Center Drive, Suite 140, Morrisville NC 27560
Manufacturer Parent Company (2017)
Tecan Group AG
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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