The Recall Desk

Manufacturer

Iso-Tex Diagnostics, Inc

2 recalls in our database name Iso-Tex Diagnostics, Inc as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
2
Most recent
2019-04-24

Of the 2 recalls from Iso-Tex Diagnostics, Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (100%) 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

  • SevereFDA (Drugs)·D-1136-2019·2019-04-24

    FDA Recalls Volumex Injection Due to Sterility Concerns

    Iso-Tex Diagnostics is recalling 54 syringes of Volumex (Iodinated I-131 Albumin) because environmental monitoring results indicate sterility cannot be assured.

    Product
    VOLUMEX — VOLUMEX (IODINATED I-131 ALBUMIN)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1008-2019·2019-03-27

    FDA Recalls Volumex Iodinated I-131 Albumin Due to Sterility Concerns

    Iso-Tex Diagnostics is recalling 54 syringes of Volumex (Iodinated I-131 Albumin) because environmental monitoring results exceeded limits, meaning sterility cannot be assured.

    Product
    VOLUMEX — VOLUMEX (IODINATED I-131 ALBUMIN)
    Category
    Drug
    Distribution
    1 state