CLASS II Device recall · Reported 14 Nov 2012 · FDA Enforcement Report
Sysmex XE-5000 Automated Hematology System recalled by Sysmex America
Sysmex America is recalling Sysmex XE-5000 Automated Hematology System, distributed nationwide in the US. The recall was initiated on 1 Jun 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0255-2013
- FDA event ID
- 62580
- Recalling firm
- Sysmex America, Mundelein, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Jun 2012
- FDA classified
- 6 Nov 2012
- Reported
- 14 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 1 Jun 2012 | Recall initiated by company | |
| 6 Nov 2012 | Classified by FDA | +158 days |
| 14 Nov 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide distribution: USA including Puerto Rico.
Questions about this recall
Why was it 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.
Which lots are affected?
catalog #063-7591-7, all serial numbers
Where was it sold?
Nationwide distribution: USA including Puerto Rico.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 62580This product is part of a recall event; the main page for the event is Sysmex XE-2100C Automated Hematology System recalled by Sysmex America.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Sysmex XE-2100C Automated Hematology System recalled by Sysmex America | Sysmex America | Other | Nationwide | |
| CLASS II | Sysmex XE-2100 Automated Hematology System recalled by Sysmex America | Sysmex America | Other | Nationwide |
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|---|---|---|---|---|---|
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