FDA Device recall Z-0255-2013
Sysmex XE-5000 Automated Hematology System
- FDA Device
- Class II
- terminated
- Published 2012-11-14
On 2012-11-14 the FDA classified a Class II recall of Sysmex XE-5000 Automated Hematology System by Sysmex America, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0255-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-06-01 |
| Published | 2012-11-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Sysmex America |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | catalog #063-7591-7, all serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0255-2013%22
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