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AVENIO Millisect

Roche Molecular Systems, Inc. · Model 08106568001 · UDI-DI 07613336146644

LXG

510(k) clearances

1,540

Adverse events (2 deaths)

Recalls

308

Facilities

Recalls

Date	Firm	Reason
2025-12-15	Sysmex America, Inc.	Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.
2025-07-16	Dynex Technologies, Inc.	The internal label affixed to the sample tip rack is incorrectly labeled as reagent tip racks. When scanned by the Agility instrument, the tip rack is misidentified as a different
2023-05-02	Helena Laboratories, Corp.	Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of missed or light samples o
2020-07-05	Dynex Technologies, Inc.	Control samples aspirated from wrong SmartKit on the Agility. Agility software was updated to v1.4.7 to resolve the issue. This leads to a risk that a control from another assay's
2020-03-09	Sysmex America, Inc.	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 door of the CF-70 t
2019-09-18	Biomedical Polymers, Inc.	The metal cannula of the device either broke and the broken piece left in the blood specimen tube, or slid back into the plastic portion of the device instead of piercing the tube.
2019-09-18	Biomedical Polymers, Inc.	The metal cannula of the device either broke and the broken piece left in the blood specimen tube, or slid back into the plastic portion of the device instead of piercing the tube.
2018-08-14	Siemens Healthcare Diagnostics, Inc.	The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
2018-08-14	Siemens Healthcare Diagnostics, Inc.	The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
2018-08-14	Siemens Healthcare Diagnostics, Inc.	The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.