The Recall Desk

Manufacturer

Clark Laboratories, Inc.

2 recalls in our database name Clark Laboratories, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2021-12-22

Of the 2 recalls from Clark Laboratories, 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.

1–2 of 2

  • ModerateFDA (Devices)·Z-0382-2022·2021-12-22

    Bartels Legionella Urinary Antigen test recalled due to reagent contamination

    Clark Laboratories is recalling the Bartels Legionella Urinary Antigen diagnostic test due to contamination in the test reagent that may cause invalid results. The affected test kits were distributed in Ohio and Utah.

    Product
    Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of Legionella Pneumophila seragroup 1 antigen in human urine. Product Code: B1029-440
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1503-2021·2021-05-05

    Trinity Biotech Captia Measles IgM Kit Recalled for Invalid Run Risk

    Clark Laboratories is recalling 80 kits of the Trinity Biotech Captia Measles IgM Kit because the positive control may run high, resulting in invalid runs and necessitating retesting.

    Product
    Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) infection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
Clark Laboratories, Inc. recalls · The Recall Desk