Reported Nov 14, 2012 · Terminated
Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan;…
Sysmex America, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sysmex America, Inc. · 1 Nelson C White Pkwy · Mundelein, IL · 60060-9528
Is this the product you have?
5 of 5 products
| Model / number | Product as published |
|---|---|
| — | 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 |
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. |
- Lot codes and dates
- catalog #063-7591-7, all serial numbers
- Amount recalled
- 763 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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