The Recall Desk

Manufacturer

Vital Diagnostics, Inc.

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

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2014-01-22

Of the 2 recalls from Vital 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 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-0733-2014·2014-01-22

    Vital Diagnostics Recalls Eon Calcium Reagent Due to High Positive Bias

    Vital Diagnostics, Inc. is recalling 213 units of Eon Calcium Reagent because high positive calcium bias was observed in plasma samples compared to serum results.

    Product
    Consult Diagnostics¿ Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 For the quantitative measurement of calcium in plasma and serum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0732-2014·2014-01-22

    Vital Diagnostics Envoy Calcium Reagent Recalled for High Positive Bias

    Vital Diagnostics is recalling Envoy Calcium Reagent (PN 55285) due to high positive calcium bias in plasma samples compared to serum results.

    Product
    Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and serum
    Category
    Medical Device
    Distribution
    Distributed nationwide