The Recall Desk

Manufacturer

Hycor Biomedical Inc

2 recalls in our database name Hycor Biomedical Inc as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2019-08-14

Of the 2 recalls from Hycor Biomedical 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

  • HighFDA (Devices)·Z-2200-2019·2019-08-14

    Hycor Biomedical Recalls HYTEC 288 System and RF Assay Kits

    Hycor Biomedical is recalling HYTEC 288 System and RF assay kits because high IgG levels may cause false positive results, leading to incorrect rheumatoid diagnoses.

    Product
    HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part Nu
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2134-2019·2019-08-07

    Hycor Biomedical Recalls AUTOSTAT II IgM Rheumatoid Factor Test Kits

    Hycor Biomedical Inc is recalling 207 units of the AUTOSTAT II IgM Rheumatoid Factor test kit due to reports of higher than anticipated positivity rates, which may cause false positive results.

    Product
    AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an automated procedure The Intended Use is as follows: Enzyme-linked immunosorbent assay method for the semi-quantitative determina
    Category
    Medical Device
    Distribution
    1 state

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Hycor Biomedical, Inc.

American biomedical corporation

Country
United States
Founded
1981

Official website

Source: Wikidata (Q17055598), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.