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Iris Diagnostics Recalls
4 recalls on record · August 8, 2012 to September 2, 2015 · Medical Devices
Recalls by year
12
13
14
15
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 2, 2015Medical DevicesFDA
Iris Diagnostics recalls iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190
Hazard: 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 iChemVELOCITY product labeling.
December 31, 2014Medical DevicesFDA
Iris Diagnostics recalls RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4
Hazard: 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.
May 22, 2013Medical DevicesFDA
Iris Diagnostics recalls Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro
Hazard: 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 the customer not being able to run patient samples.
August 8, 2012Medical DevicesFDA
Iris Diagnostics recalls IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpe
Hazard: 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.