Recall Z-1597-2023 ยท KQO Automated Urinalysis System
Beckman Coulter, Inc.
DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis
| Date | May 17, 2023 (initiated Apr 5, 2023) |
| Status | Open, Classified |
| Reason | Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated. |
| Root cause | Under Investigation by firm |
| Action | Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 04/05/2023 by mail. The notice explained the issue and the hazard and requested the following actions be taken: "Examine your specimen settings to determine if the optional 'Sperm Present' and 'Previous Sample Had Sperm' flags are enabled. If disabled, no further action is needed by your laboratory. If enabled, follow the actions below If the presence of sperm is identified: Review the previous specimen for the presence of sperm. Follow recommendations under Previous Sample Had Sperm in the iQ200 Series |
| Quantity | 107 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |