The Recall Desk

Manufacturer

IMMUNDIAGNOSTIK, Inc

1 recall in our database name IMMUNDIAGNOSTIK, Inc as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2023-05-24

Of the 1 recalls from IMMUNDIAGNOSTIK, Inc 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-1603-2023·2023-05-24

    Immundiagnostik Lactoferrin ELISA Kit Recalled for Lacking FDA 510(k) Clearance

    IMMUNDIAGNOSTIK Inc. has recalled the IDK Lactoferrin ELISA diagnostic kit because it was marketed without the required FDA 510(k) premarket notification. No illnesses or injuries have been reported.

    Product
    Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870 Single Kit P/N: K6870.20.US.L 20 Plates
    Category
    Medical Device
    Distribution
    Distributed nationwide