# FDA recall Z-1222-2018

> **Inova Diagnostics Incorporated** · Class II · device recall initiated 2018-01-26.

## 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 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.

## Distribution

There was no U.S. distribution.  Distribution was made to Panama and United Kingdom.

## Key facts

- **Recall number:** Z-1222-2018
- **Recalling firm:** Inova Diagnostics Incorporated
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-26
- **Report date:** 2018-04-04
- **Termination date:** 2018-05-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1222-2018

## Citation

> AI Analytics. FDA recall Z-1222-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1222-2018. Source: US FDA. Licensed CC0.

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