Recall Z-1384-2017 ยท KQO Automated Urinalysis System
Beckman Coulter Inc.
iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061. The iChem Velocity automated urine chemistry system is used to test for the following analytes in urine: ketones, blood, protein, glucose, bilirubin, urobilinogen, nitrite, leukocyte esterase, specific gravity, pH, ascorbic acid,
| Date | Mar 1, 2017 (initiated Jan 30, 2017) |
| Status | Terminated |
| Reason | The probe misalignment or bending has the potential to lead to delay in reporting results or incorrect patient results. |
| Root cause | Device Design |
| Action | Beckman Coulter/Iris sent an Urgent Medical Device Recall letter dated January 30, 2017 to all affected customers to inform them that Iris International has determined that sample probe misalignment or bending on the iChemVELOCITY may lead to a remote possibility of false negative results due to inadequate strip dosing. Customers were informed that Inadequate dosing may lead to incorrect patient results which may not be detected by quality control, or to a delay in reporting results. Incorrect patient results might be observed as an unexpected discrepancy between instrument results and the pa |
| Quantity | 3175 units total (1697 units in US) |
| Distribution | Worldwide Distribution - US (nationwide) and internationally to Argentina, Australia, Austria, Bangladesh, Belarus, Bolivia, Bosnia and Herzegovina, Brazil, Brunei, Canada, Chile, China, Columbia, Croatia, Czech Republic, Ecuador, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Israe |
| 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 |