Iris Diagnostics
Country not established
- Devices
- 2
- FDA recalls
- 4
At a glance
Market reach
- United States
- FDA recalls
What Iris Diagnostics makes
Iris Diagnostics manufactures the IQ 200 Urine Analyzer, a modular device for analyzing body fluids, including urine. The company also produces the Irispec series, consisting of models CA, CB, and CC, which are designed for specific diagnostic testing.
The IQ 200 Urine Analyzer and Irispec series are regulated under FDA 510(k) clearance, with device classifications including Class I and Class II. These products are listed in the FDA’s 510(k) registry. The company is based in the United States.
Catalogue
Iq 200 Urine Analizer Body Fluids Module Ref K091539
Regimes: 510(k) Registry: 510(k)Irispec, Ca/Cb/Cc Ref K072640
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 4 recalls initiated by Iris Diagnostics, the earliest on 2012-07-09 and the most recent on 2015-07-15. By recorded status: 4 terminated. The reasons filed fall into these groups: labeling or instructions for use, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2015
- 15 Jul 2015 Z-2441-2015 Class II Terminated 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.
Full distribution text
- 15 Jul 2015 Z-2441-2015 Class II Terminated 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.
2014
- 3 Dec 2014 Z-0857-2015 Class II Terminated 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.
Full distribution text
- 3 Dec 2014 Z-0857-2015 Class II Terminated 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.
2012
- 18 Sep 2012 Z-1328-2013 Class II Terminated 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.
Full distribution text
- 9 Jul 2012 Z-2124-2012 Class III Terminated 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.
- 18 Sep 2012 Z-1328-2013 Class II Terminated 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.
Frequently asked questions
How many devices does Iris Diagnostics have in the registry?
The registry currently lists 2 devices for Iris Diagnostics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Iris Diagnostics's devices?
Among its 2 most recently registered devices, Iris Diagnostics has devices listed in FDA 510(k) (2 devices).
What risk classes do Iris Diagnostics's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Iris Diagnostics's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Iris Diagnostics?
FDA recall records list 4 recalls initiated by Iris Diagnostics, the most recent initiated on 15 Jul 2015. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Iris Diagnostics in the registry?
The most recently registered devices listed for Iris Diagnostics include IQ 200 URINE ANALIZER BODY FLUIDS MODULE and IRISPEC, CA/CB/CC.