Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan
Published May 10, 2017 · Recall initiated: March 23, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sysmex America Inc
- Distributor
- Nationwide, Canada
- Lot
- **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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.