| | Class 2 Recall
Sysmex XE-2100 Automated Hematology System |  |
| Date Posted |
November 06, 2012 |
| Recall Number |
Z-0254-2013 |
| Product |
Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #983-1341-1
The Sysmex XE-2100 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-2100 performs hematology analyses according to the RF/DC detection method, HydroDynamic Focusing (DC Detection), flow cytometry method (using a semiconductor laser), and SLS-hemoglobin method. |
| Code Information |
catalog #983-1341-1, all serial numbers
|
Recalling Firm/
Manufacturer |
Sysmex America, Inc.
1 Nelson C White Pkwy
Mundelein, Illinois 60060-9528 |
| Consumer Instructions |
Contact the recalling firm for information |
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.
|
| Action |
Sysmex America, Inc. sent a "PRODUCT NOTIFICATION" letter dated May 2012 to all affected customers on June 1, 2012. The letter identifies the product, problem, and actions to be taken. The letter instructs customers to review patient results to determine if their Reference Intervals need adjustment, and to review QC results via Insight and document any change that may be linked to the date of calibration if appropriate.
Any questions concerning the information contained in the notification were directed to the Sysmex Technical Assistance Center at 1-888-879-7639. |
| Quantity in Commerce |
1,099 units |
| Distribution |
Nationwide distribution: USA including Puerto Rico. |
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