CLASS II Device recall · Reported 14 Nov 2012 · FDA Enforcement Report
Sysmex XE-2100C Automated Hematology System recalled by Sysmex America
Sysmex America is recalling Sysmex XE-2100C 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-0256-2013
- 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-2100C Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #053-2311-4 The Sysmex XE-2100C is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.
Where it was distributed
Nationwide distribution: USA including Puerto Rico.
Questions about this recall
Is Sysmex XE-2100C Automated Hematology System recalled?
Yes. Sysmex America recalled Sysmex XE-2100C Automated Hematology System on 1 Jun 2012. The recall is Class II and its status is Terminated. Recall number Z-0256-2013.
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 ##053-2311-4, 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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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