The Recall Desk

Manufacturer

ELITech Group B.V.

1 recall in our database name ELITech Group B.V. as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2019-10-09

Of the 1 recalls from ELITech Group B.V. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • LowFDA (Devices)·Z-2764-2019·2019-10-09

    ELITech Viva-ProE Systems Recalled for Software Malfunction

    ELITech Group B.V. is recalling 89 Viva-ProE Systems because a software malfunction causes the devices to become inoperable.

    Product
    Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been appli
    Category
    Medical Device
    Distribution
    Distributed nationwide