The Recall Desk

Manufacturer

Iris Diagnostics

4 recalls in our database name Iris Diagnostics as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2015-09-02

Of the 4 recalls from Iris Diagnostics 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.

1–4 of 4

  • ModerateFDA (Devices)·Z-2441-2015·2015-09-02

    Iris Diagnostics Recalls iChemVELOCITY Urine Chemistry Systems for Labeling Error

    Iris Diagnostics is recalling iChemVELOCITY Automated Urine Chemistry systems because they do not maintain the claimed 5-day strip stability under specified conditions.

    Product
    iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714, 800-7719, 800-7720. An in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0857-2015·2014-12-31

    Iris Diagnostics Recalls RTH8 Rotor for StatSpin Express 4 Centrifuge

    Iris Diagnostics is recalling RTH8 rotors for the StatSpin Express 4 Horizontal Centrifuge because the parts may develop cracks with use over time.

    Product
    RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4. The RTH8 rotor is used with the Statspin Express 4 Horizontal Centrifuge. StatSpin Express 4 Centrifuge: For in vitro diagnostic use to produce the rapid s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1328-2013·2013-05-22

    Iris Diagnostics Recalls iQ Control/Focus Sets Due to Performance Issues

    Iris Diagnostics is recalling iQ Control/Focus Sets because customer complaints indicated the product failed to meet performance specifications, preventing patient sample testing.

    Product
    Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2124-2012·2012-08-08

    Iris Diagnostics Recalls Urine Chemistry Control Material Due to Inaccurate Results

    Iris Diagnostics is recalling IRISpec CA/CB urine chemistry control material because nitrite results were incorrectly negative.

    Product
    IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) us
    Category
    Medical Device
    Distribution
    Distributed nationwide