Sysmex America, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0255-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 1, 2012

Date Posted: November 14, 2012

Recall Number: Z-0255-2013

Event ID: 62580

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.

Status: Terminated

Product Quantity: 763 units

Code Information:

catalog #063-7591-7, all serial numbers

Distribution Pattern:

Nationwide distribution: USA including Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated