Iris Diagnostics
Iris Diagnostics appears in FDA public data with 4 recalls, 2 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2441-2015, Class II) was initiated on July 15, 2015. Its most recent 510(k) clearance was granted on August 31, 2010.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 2
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2441-2015 | Class II | iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530 | July 15, 2015 |
| Z-0857-2015 | Class II | RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M5 | December 3, 2014 |
| Z-1328-2013 | Class II | Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product | September 18, 2012 |
| Z-2124-2012 | Class III | IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. | July 9, 2012 |