Recall Z-1221-2018— Inova Diagnostics Incorporated
Class II · Terminated
Class II FDA medical device recall by Inova Diagnostics Incorporated, initiated 2018-01-26, terminated 2018-05-22. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Inova Diagnostics Incorporated
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-01-26
- Terminated
- 2018-05-22
- Firm location
- San Diego, CA, United States
Product 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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.