FDA Device recall Z-2441-2015
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
- terminated
- Published 2015-09-02
On 2015-09-02 the FDA classified a Class II recall of iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714… by Iris Diagnostics, citing 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 hum….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2441-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-15 |
| Published | 2015-09-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Iris Diagnostics |
| Distribution | US |
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 Strips.
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 iChemVELOCITY product labeling.
Identifiers
| code_info | All Serial Numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Iris Diagnostics
- RTH8 Rotor, P/N X01-005847-001
FDA Device · Class II · 2014-12-31 · Iris Diagnostics - Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12
FDA Device · Class II · 2013-05-22 · Iris Diagnostics - 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
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2441-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.