TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running s
Summary
The FDA issued a Class II for TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample t by Sysmex America, Inc.. Reason: Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift..
Details
Source
Device Recall
External ID
Z-1136-2026
Action Date
2026-01-28
Status
Ongoing
Category
device
Product Description
TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17
Lot/Code Info: 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
Quantity Affected: 44 units
Reason for Recall
Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-15
Company
Lincolnshire, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 180 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Sysmex America, Inc. has 7 FDA actions in our database, including 2 recalls and 5 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Sysmex America, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sysmex America, Inc. have FDA actions?
Sysmex America, Inc. has 7 FDA actions in our database, including 2 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1136-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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