QUANTA-Lyser 240 IFA — Class II medical device recall Z-1221-2018
Terminated recall by Inova Diagnostics Incorporated, reported 2018-04-04. The device power supply was not manufactured according to specification which can result in the loss of the pr
| Recall number | Z-1221-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Inova Diagnostics Incorporated, San Diego, CA, United States |
| Recall initiated | 2018-01-26 |
| Classified | 2018-03-27 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2018-05-22 |
| Countries outside the US | GB, PA |
| Quantity | 1 instrument |
| Serial numbers | 4314 |
| Model numbers | GS0242 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1221-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.