The Recall Desk

Manufacturer

Biocartis Nv

1 recall in our database name Biocartis Nv as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2025-01-22

Of the 1 recalls from Biocartis Nv 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

  • HighFDA (Devices)·Z-0836-2025·2025-01-22

    Idylla diagnostic INSTRUMENT recalled due to false-positive MSI-H test results

    The Biocartis Idylla INSTRUMENT, an in vitro diagnostic device, has been recalled due to false-positive results in MSI-H testing. These false-positive results could lead to inaccurate diagnoses.

    Product
    Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla Cartridges.
    Category
    Medical Device
    Distribution
    5 states