Recall Z-0255-2013 ยท GKZ Counter, Differential Cell
Sysmex America, Inc.
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 followi
| Date | Nov 6, 2012 (initiated Jun 1, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| 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 | 763 units |
| Distribution | Nationwide distribution: USA including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071967 | SYSMEX XE-5000 Sysmex America, Inc., Nov 20, 2007 |