HIGH

Sysmex America Recalls Tube Sorter Due to Lift Hazard

Sysmex America recalled 44 units of the TS-10/TS-10H Tube Sorter on December 15, 2025. The electromagnetic holding force may disengage, causing unintended movement. Healthcare providers should stop using the device immediately.

Quick Facts at a Glance

Recall Date
December 15, 2025
Hazard Level
HIGH
Brand
Sysmex America
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Sysmex America, Inc. or your healthcare provider for instructions. Notification method: Letter

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About This Product

The TS-10/TS-10H Tube Sorter is an automatic sorting system designed for efficiently organizing barcoded sample tubes. Healthcare facilities commonly use this device to streamline lab processes and minimize errors in sample handling.

Why This Is Dangerous

The device's lift mechanism relies on an electromagnetic holding force that can disengage unexpectedly. This disengagement poses a significant risk of the lift moving downward, which can lead to accidents or injuries.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Users of the TS-10/TS-10H Tube Sorter must stop using the device to avoid potential safety hazards. This recall can cause operational disruptions in healthcare settings that rely on the sorter for sample management.

Practical Guidance

How to identify if yours is affected

  1. Identify the Catalog Number BN168792 on your device.
  2. Verify that your Tube Sorter is running software versions 00-17.
  3. Check the serial numbers listed in the recall to see if yours is affected.

Where to find product info

The Catalog Number and serial number are typically located on the product's identification label, which may be on the back or bottom of the device.

What timeline to expect

Expect a timeline of 4-6 weeks for receiving a refund or replacement after submitting your request.

If the manufacturer is unresponsive

  • Document all attempts to contact Sysmex America.
  • Reach out to the FDA for further assistance if necessary.
  • Consider filing a complaint if the company remains unresponsive.

How to prevent similar issues

  • Look for devices with enhanced safety features in the future.
  • Check for product safety certifications before purchase.
  • Research user reviews and safety reports on medical devices before buying.

Documentation advice

Keep a record of your purchase receipt, correspondence with Sysmex, and any relevant photos of the device.

Product Details

The recall affects the TS-10/TS-10H Tube Sorter, Catalog Number BN168792, running software versions 00-17. These devices were distributed nationwide in the United States.

Key Facts

  • 44 units recalled
  • Catalog Number: BN168792
  • Running software versions: 00-17
  • Class II recall
  • Nationwide distribution

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Serial Numbers: 11281 11611 11918 11790 12040 11991 12218 11950 11795 11533 11635 12054 11610 11453 11753 11539 11990 12298 11774 11541 11981 11788 11834 12005 11907 11524 12237 11246 12154 12104 12299 12176 11711 11420 12153 12177 12074 11405 11303 12039 11250 11336 12137 12075
Affected States
ALL
Report Date
January 28, 2026
Recall Status
ACTIVE

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