Z-1222-2018 Class II Terminated
FDA device recall Z-1222-2018 was initiated by Inova Diagnostics Incorporated on January 26, 2018 and is designated Class II. Reason for recall: The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument. The recall status is terminated (terminated May 22, 2018). Affected quantity: 1 instrument.
Recall Details
- Product Type
- Devices
- Report Date
- April 4, 2018
- Initiation Date
- January 26, 2018
- Termination Date
- May 22, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 instrument
Product Description
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.
Reason for Recall
The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument.
Distribution Pattern
There was no U.S. distribution. Distribution was made to Panama and United Kingdom.
Code Information
Serial number 4316