Class II — Inova Diagnostics Incorporated
| Recalling firm | INOVA DIAGNOSTICS, INC. |
|---|---|
| Registered facility | INOVA DIAGNOSTICS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument. |
| 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. |
| Quantity | 1 instrument |
| Distribution | There was no U.S. distribution. Distribution was made to Panama and United Kingdom. |
| Initiated | 2018-01-26 |
| Classified | 2018-03-27 |
| Terminated | 2018-05-22 |
| Recall number | Z-1221-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Inova Diagnostics Incorporated (Z-1221-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79380/
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