CLASS II Device recall · Reported 10 May 2017 · FDA Enforcement Report

Sysmex, Automated Hematology Analyzer XN Series recalled

Sysmex America is recalling Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1, distributed nationwide in the US. The recall was initiated on 23 Mar 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes**Model: XN-10, Product Number: AP795756, Serial Numbers: 11001 29656, 29668-29786, 29788-29798, 29800-29801, 29803, 29804, 29807, 29812, 29816-29867 **Model: XN-11, Product Number: CS297931, Serial Numbers: A1001-A1124, A1127, A1130, A1135-A1140, A1142-A1144, A1146-A1149, A1151, A1153-A1159, A1161, A1163, A1171

Quantity recalled3,682 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-2034-2017
FDA event ID: 76828
Recalling firm: Sysmex America, Lincolnshire, IL
Classification: Class II
Status: Terminated
Recall initiated: 23 Mar 2017
FDA classified: 4 May 2017
Reported: 10 May 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Test Kits & Diagnostics

Timeline

23 Mar 2017	Recall initiated by company
4 May 2017	Classified by FDA	+42 days
10 May 2017	Published in enforcement report	+6 days

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

Reason for recall

Reported customer complaints of automated hematology analyzers catching fire due to misalignment of an internal protective sheet that shields electronic components from salty reagents. Build-up of salt deposits on unprotected electronic components may combust due to heat generated by electronics when instrument cycles. Completed CAPA identified the root cause as supplier providing defective component (sensor ready valve) and the misalignment of the electronic protective shield during manufacturing of the device.

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

Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan

Where it was distributed

Nationwide, Canada

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

**Model: XN-10, Product Number: AP795756, Serial Numbers: 11001 29656, 29668-29786, 29788-29798, 29800-29801, 29803, 29804, 29807, 29812, 29816-29867 **Model: XN-11, Product Number: CS297931, Serial Numbers: A1001-A1124, A1127, A1130, A1135-A1140, A1142-A1144, A1146-A1149, A1151, A1153-A1159, A1161, A1163, A1171

Where was it sold?

Nationwide, Canada

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.

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