Date Initiated by Firm | June 01, 2012 |
Date Posted | November 06, 2012 |
Recall Status1 |
Terminated 3 on August 22, 2016 |
Recall Number | Z-0256-2013 |
Recall Event ID |
62580 |
510(K)Number | K051457 |
Product Classification |
Counter, differential cell - Product Code GKZ
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Product | 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. |
Code Information |
catalog ##053-2311-4, all serial numbers |
Recalling Firm/ Manufacturer |
Sysmex America, Inc. 1 Nelson C White Pkwy Mundelein IL 60060-9528
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For Additional Information Contact | 888-879-7639 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 in Commerce | 69 units |
Distribution | Nationwide distribution: USA including Puerto Rico. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = GKZ
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