Z-0255-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 14, 2012
- Initiation Date
- June 1, 2012
- Termination Date
- August 22, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 763 units
Product Description
Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #063-7591-7 The Sysmex XE-5000 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-5000 performs analyses using the following methods: RF/DC Detection Method, Sheath Row DC Detection Method, and Flow Cytometry Methods using a Semiconductor Laser. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. Using the same reagents as the XE-2100, the XE-5000 automatically classifies cells from blood and body fluids and carries out all processes automatically from aspiration of the sample to outputting the results.
Reason for Recall
There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i, XT-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lower on the XE-Series because of a low bias.
Distribution Pattern
Nationwide distribution: USA including Puerto Rico.
Code Information
catalog #063-7591-7, all serial numbers