Recall Z-1535-2020 ยท KQO Automated Urinalysis System
Beckman Coulter, Inc.
iChemVELOCITY Strips, Catalog 800-7212
| Date | Feb 17, 2020 |
| Status | Terminated |
| Reason | The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device Recall letter will be sent during the week of 02/17/2020 to the affected customers via email and mail. Customers are advised to discard the affected product and order a replacement from BEC. |
| Quantity | 10822 vials |
| Distribution | Distribution in US including Puerto Rico, Canada, and Taiwan |
| 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 |