Z-2034-2017 Class II Terminated
FDA device recall Z-2034-2017 was initiated by Sysmex America Inc on March 23, 2017 and is designated Class II. 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 sa… The recall status is terminated (terminated August 22, 2019). Affected quantity: 3,682 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 10, 2017
- Initiation Date
- March 23, 2017
- Termination Date
- August 22, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,682 units
Product Description
Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan
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.
Distribution Pattern
Nationwide, Canada
Code Information
**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