CLASS II ONGOING Device recall · Reported 28 Jan 2026 · FDA Enforcement Report

TS-10/TS-10H Tube Sorter, automatic sorting system recalled

Sysmex America is recalling TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, distributed nationwide in the US. The recall was initiated on 15 Dec 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial 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 recalled44 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1136-2026
FDA event ID: 98213
Recalling firm: Sysmex America, Lincolnshire, IL
Classification: Class II
Status: Ongoing
Recall initiated: 15 Dec 2025
FDA classified: 21 Jan 2026
Reported: 28 Jan 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

15 Dec 2025	Recall initiated by company
21 Jan 2026	Classified by FDA	+37 days
28 Jan 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17

Where it was distributed

US Nationwide.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

US Nationwide.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Sysmex America

All 14

Reported	Class	Recall	Company	Reason	Where
12 Feb 2025Device	CLASS II	Sysmex PS-10 Sample Preparation System recalled by Sysmex America	Sysmex America	Device Malfunction	Nationwide
29 Jul 2020Device	CLASS II	Sysmex PS-10 Sample Preparation System recalled by Sysmex America	Sysmex America	Device Malfunction	Nationwide
22 Apr 2020Device	CLASS II	The CF-70 instrument (product recalled by Sysmex America	Sysmex America	Device Malfunction	Nationwide
22 Apr 2020Device	CLASS II	Sysmex CV-11 Sample Unit, an integrated modular sampler recalled	Sysmex America	Other	FL, IL, VT
5 Sep 2018Device	CLASS II	Sysmex XN-Series Fluorocell PLT recalled by Sysmex America	Sysmex America	Other	Nationwide

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