FDA Device recall Z-1222-2018
QUANTA-Lyser 240 EIA, Part #GS0241
- FDA Device
- Class II
- terminated
- Published 2018-04-04
On 2018-04-04 the FDA classified a Class II recall of QUANTA-Lyser 240 EIA, Part #GS0241 by Inova Diagnostics, citing the device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1222-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-26 |
| Published | 2018-04-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Inova Diagnostics |
| Distribution | n/a |
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.
Reason
The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument.
Identifiers
| code_info | Serial number 4316 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1222-2018%22
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