Recall Z-2441-2015 ยท KQO Automated Urinalysis System
Iris Diagnostics
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.
| Date | Aug 21, 2015 (initiated Jul 15, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | An Urgent Medical Device Recall letter dated 7/15/15 was sent to all customers who purchased the iChemVELOCITY Automated Urine Chemistry System using iChemVELOCITY Urine Chemistry Strips REF 800-7212 and 800-7212-001. As a result of internal investigations following customer complaints, Iris International has determined that the iChemVELOCITY systems do not maintain the on-board strip stability claim of 5 days at 18-28C at 20-80% relative humidity (RH) as stated in the iChemVELOCITY product labeling. The letter informs the customers of the problems identified and the actions to be taken. Cu |
| Quantity | 2,448 units |
| Distribution | Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Argentina, Australia, Austria, Bahrain, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Ecuador, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Jor |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101852 | CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT Iris International Inc., A Division of Iris Iris I, Mar 23, 2011 |