Agency classClass IIOur severity:Severe FDA (Devices)·Z-2034-2017·Announced 2017-05-10

Sysmex XN Series Hematology Analyzers Recalled for Fire Risk

Sysmex America Inc is recalling XN-10 and XN-11 hematology analyzers due to a risk of fire caused by misaligned internal protective sheets.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly reports that the analyzers caught fire, which constitutes a significant property-damage report and a risk of serious injury, meeting the criteria for a Severe (4) rating.

Plain-English summary

Sysmex America Inc is recalling 3,682 units of the Automated Hematology Analyzer XN Series, specifically models XN-10 and XN-11. The recall is due to customer complaints that the analyzers caught fire. The fire risk is caused by the misalignment of an internal protective sheet that is designed to shield electronic components from salty reagents.

When the protective sheet is misaligned, salt deposits can build up on unprotected electronic components. These deposits may combust due to the heat generated by the electronics when the instrument cycles. A completed corrective and preventive action (CAPA) identified the root cause as a supplier providing a defective sensor ready valve and the misalignment of the electronic protective shield during manufacturing.

The affected units were distributed nationwide in the United States and in Canada. Users of these devices should contact Sysmex America Inc for instructions on how to address the defect and prevent potential fire hazards.

The recalled product

Product: Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan
Manufacturer: Sysmex America Inc
Category: Medical Device — Laboratory Equipment
Hazard: fire
Affected units: 3,682

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

**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

Distribution

Distributed nationwide across the United States.

Same manufacturer · Sysmex America Inc

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