The Recall Desk

FDA (Devices) recall action 79380

Inova Diagnostics Incorporated recalled 2 products on 2018-04-04

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2018-04-04
Critical
0
Units
2

Why these products were recalled

The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··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.

    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-04-04

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

    Inova Diagnostics is recalling one QUANTA-Lyser 240 IFA instrument because its power supply was not manufactured to specification, potentially causing loss of protective grounding.

    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, disp
    Category
    Distribution
    0 states