Device product
Infinite F50 instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and instrument specifications; they are therefore for professional use in in-vitro diagnostics
Z-2660-2016
Product summary
- Firm
- Tecan US, Inc.
- Event
- Event 74806
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-2660-2016
Official wording
Reason: The batteries have the potential to overheating, melt or char.
Code information: Instrument Material #330087508, PC Serial # CND5219H07, Instrument Serial #1508007738.
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.