The Recall Desk
HighFDA (Devices)·Z-1222-2018·Announced 2018-04-04

Inova Diagnostics Recalls QUANTA-Lyser 240 EIA Due to Power Supply Defect

Inova Diagnostics is recalling one QUANTA-Lyser 240 EIA instrument because a defective power supply may cause loss of protective grounding.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (loss of protective grounding) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Inova Diagnostics Incorporated is recalling one unit of the QUANTA-Lyser 240 EIA, Part #GS0241, serial number 4316. The device 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.

The recall was initiated because the device power supply was not manufactured according to specification. This defect can result in the loss of the protective grounding of the instrument.

There was no U.S. distribution of the affected unit. Distribution was made to Panama and the United Kingdom.

The recalled product

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, disp
Manufacturer
Inova Diagnostics Incorporated
Category
Medical Device — Laboratory Equipment
Hazard
Affected units
1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial number 4316

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Inova Diagnostics Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Inova Diagnostics Incorporated

See all →

Same hazard · electrical shock

See all →