Iris Diagnostics recalls
Iris Diagnostics appears in 4 official U.S. recall notices indexed by RecallRadar, most recently on 2015-09-02.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 4 |
|---|---|
| Published | 2012-08-08 to 2015-09-02 |
| By agency | FDA Device (4) |
| By classification | Class II (3), Class III (1) |
| By status | terminated (4) |
| Distribution named in notices | US |
Recalls
- iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714…
FDA Device · Class II · 2015-09-02 · Iris Diagnostics
Reason: Iris International is recalling the iChemVELOCITY systems because they do not maintain the on-board strip stability claim of 5 days at 18-28 degrees celsius at 20-80% relative humidity (RH) as stated in the iChemVELOCIT… - RTH8 Rotor, P/N X01-005847-001
FDA Device · Class II · 2014-12-31 · Iris Diagnostics
Reason: Iris International is recalling the RTH8 Rotor used in the StatSpin Express 4 Horizontal Centrifuge because the RTH8 rotor may develop cracks with use over time. - Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12
FDA Device · Class II · 2013-05-22 · Iris Diagnostics
Reason: The firm initiated this recall because complaints from customers reported that the recovery compared to assigned assay values is significantly below specification. This results in the instrument not passing controls and… - IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074
FDA Device · Class III · 2012-08-08 · Iris Diagnostics
Reason: The firm recalled after it received complaints of IRISpec CA/CB two part Urine Chemistry Control, 101131-12, where the nitrite results read negative for the part B control, which should be positive.