Device product
QUANTA-Lyser 240 EIA, Part #GS0241. The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting medium in the preparation for microscope analysis, and photometric measurement of microwell plates.
Z-1222-2018
Product summary
- Event
- Event 79380
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 instrument
- Official record key
device-enforcement:Z-1222-2018
Official wording
Reason: The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument.
Code information: Serial number 4316
Distribution pattern: There was no U.S. distribution. Distribution was made to Panama and United Kingdom.
Derived failure modes
-
Unknown
The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument.