| 2025-12-15 |
Class II
|
Ongoing |
Z-1136-2026 |
TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running s… |
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Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift. |
| 2025-01-06 |
Class II
|
Ongoing |
Z-1113-2025 |
Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for a… |
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Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash step during antibody pipetting on the PS-… |
| 2020-07-06 |
Class II
|
Terminated |
Z-2687-2020 |
Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automated, user configurable… |
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Insufficient amount of antibody without an error message or alarm |
| 2020-03-09 |
Class II
|
Terminated |
Z-1703-2020 |
The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears… |
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Software mismatch-When the software versions between the SP-50 and CF-70 are not matched, and an error condition occurs requiring the operator to open the cover… |
| 2020-01-21 |
Class II
|
Terminated |
Z-1717-2020 |
Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers. |
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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 … |