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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Sysmex America
- Product type
- Automatic Sorting System
- 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
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 15, 2025
Reported by FDA DEVICE
January 28, 2026
RecallRadar source check
February 4, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Identify the Catalog Number BN168792 on your device.
- Verify that your Tube Sorter is running software versions 00-17.
- 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.
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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
- Catalog Number: BN168792
- Running software versions: 00-17
- Class II recall
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Safety Guide
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