Z-2666-2016 Class II Terminated
FDA device recall Z-2666-2016 was initiated by Tecan US, Inc. on July 25, 2016 and is designated Class II. Reason for recall: The batteries have the potential to overheating, melt or char. The recall status is terminated (terminated January 23, 2017). Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- August 31, 2016
- Initiation Date
- July 25, 2016
- Termination Date
- January 23, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
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).
Reason for Recall
The batteries have the potential to overheating, melt or char.
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.
Code Information
Instrument Material #30087532, PC Serial #2CE4240D4X, Instrument Serial # 1411004534.