Recall Z-1944-2020 ยท KQO Automated Urinalysis System
Beckman Coulter Inc.
iChemVELOCITY Urine Chemistry System-
| Date | May 9, 2020 (initiated Mar 30, 2020) |
| Status | Terminated |
| Reason | A defect in the SATA power adapter cable within the instruments computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or melting of the SATA adapter cable within the computers metal enclosure, smoke emanating from PC6, flames contained within PC6, or an inability to use the devices CD-ROM. |
| Root cause | Nonconforming Material/Component |
| Action | On 03/25/2020 Beckman Coulter Inc. sent out Urgent Medical Device Alert identifying the problem, the circumstances in which it can occur, the actions that should be taken by the customer/user in order to prevent risks to patients or users, and the actions planned by Beckman Coulter to correct the problem. PRODUCTS: Products installed between July of 2012 and December of 2014 are in scope of this field corrective action and can be identified by the name of the Product (all part numbers) that were installed in the time frames noted. ACTION TO BE TAKEN BY CUSTOMER/USER: If flames and or smoke b |
| Quantity | 1557 units |
| Distribution | US Distribution: Nationwide Foreign Distribution: Worldwide |
| 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 |