Enforcement Report - Week of November 14, 2012
-
Back to Previous Page
Product Detail
| 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. |
|---|---|
| Recall Number | Z-0255-2013 |
| Classification | Class II |
| Code Info | catalog #063-7591-7, all serial numbers |
| Product Distributed Qty | 763 units |
| 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. |
Event Detail
| Event Id | 62580 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Sysmex America, Inc. |
| City | Mundelein |
| State | IL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-06-01 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide distribution: USA including Puerto Rico. |
-
