Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sys
FDA device recall Z-0254-2013 · posted 2012-11-06 · Terminated
Recall details
- Recalling firm
- Sysmex America, Inc.
- 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 taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 1,099 units
- Distribution
- Nationwide distribution: USA including Puerto Rico.
- Date initiated
- 2012-06-01
- Date posted
- 2012-11-06
- Date terminated
- 2016-08-22
- Location
- Mundelein, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER (K992875) | Sysmex Corp. | 1999-11-09 |