FDA-Device2026-01-28Class IIPROCESSING DEFECT
Sysmex TS-10/TS-10H Tube Sorter recalled for unexpected lift disengagement
What this means
Sysmex America's TS-10/TS-10H Tube Sorter may experience an unexpected loss of electromagnetic holding force in the lift mechanism under certain conditions. This could cause the lift to move downward unintentionally. The issue affects 44 specific units identified by serial number.
- Check if your unit's serial number matches the recall list (contact Sysmex America with your serial number if unsure)
- Stop using the affected sorter until you receive further instructions from Sysmex America
- Contact Sysmex America for repair or replacement options
- Review any standard operating procedures to avoid the specific conditions that may trigger the issue
The agency's original wording
Hazard
Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide.
Affected count
44 units
Manufactured in
577 Aptakisic Rd, Lincolnshire, IL, United States
Products
TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1136-2026Want us to check the next one for you?
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