Reported May 10, 2017 · Terminated
Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe…
Sysmex America Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sysmex America Inc · 577 Aptakisic Rd · Lincolnshire, IL · 60069-4325
Is this the product you have?
- Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan
- Lot codes and dates
- **Model: XN-10
- Product NumberAP795756
- Serial Numbers
11001 2965629668-2978629788-2979829800-298012980329804298072981229816-29867 **Model: XN-11
- Product NumberCS297931
- Serial Numbers
A1001-A1124A1127A1130A1135-A1140A1142-A1144A1146-A1149A1151A1153-A1159A1161A1163A1171
- Amount recalled
- 3,682 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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