Inova Diagnostics Incorporated: Medical Device Recall in 2018 - (Recall #: Z-1222-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 26, 2018

Date Posted: April 4, 2018

Recall Number: Z-1222-2018

Event ID: 79380

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.

Status: Terminated

Product Quantity: 1 instrument

Code Information:

Serial number 4316

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated