Recall Z-1717-2020 ยท KQO Automated Urinalysis System
Sysmex America, Inc.
Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.
| Date | Jan 21, 2020 |
| Status | Terminated |
| Reason | When excessive amounts of urine spills on the rack transport track and reaches the electrical components of the CV-11 conveyor, there is a potential for smoke and/or sparks which may present a combustion hazard. |
| Root cause | Process control |
| Action | The firm initiated the recall by letter on January 21, 2020. The "Product Notification", identified the Field Correction and instructed the customer to use the kit to direct fluid safety away from the conveyor electrical parts to address this potential hazard. During the next service visit, this kit will be installed by your Sysmex Field Service Engineer. The Notification also instructs the customer to: 1. Ensure that the surface of the sample, in the two, is more than away from the opening of the two. 2. Do not store samples on or above the analyzer. 3. if the sample transport convey |
| Quantity | 40 units |
| Distribution | USA: FL, VT, IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.