FDA Enforcement
Class II
Terminated
QUANTA-Lyser 240 IFA, Part #GS0242. 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.
Recall: Z-1221-2018
·
Reported April 4, 2018
Enforcement
- Recall Number
- Z-1221-2018
- Event ID
- 79380
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Inova Diagnostics Incorporated
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 4, 2018
- Initiation Date
- January 26, 2018
- Classification Date
- March 27, 2018
- Termination Date
- May 22, 2018
- Address
- 9900 Old Grove Rd, San Diego, CA, 92131-1638, United States
Description
QUANTA-Lyser 240 IFA, Part #GS0242. 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
The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument.
Code Info
Serial number 4314
Distribution
There was no U.S. distribution. Distribution was made to Panama and United Kingdom.
Quantity
1 instrument