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U.S. Department of Health and Human Services

Class 2 Device Recall Beckman Coulter UniCel DxI 800

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 Class 2 Device Recall Beckman Coulter UniCel DxI 800see related information
Date Initiated by FirmJuly 06, 2010
Date PostedJune 28, 2011
Recall Status1 Terminated 3 on May 07, 2012
Recall NumberZ-2685-2011
Recall Event ID 56408
510(K)NumberK023764 
Product Classification Immunoassay System - Product Code JJE
ProductBeckman Coulter UniCel DxI 800 Access Immunoassay System with Unicel DXI system software version 4.3
Code Information Part Numbers: A71456, 973100, A25288, A25285 with Unicel DXI system software version 4.3
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
200 S Kraemer Blvd
Brea CA 92821-6208
For Additional Information ContactClair K. O'Donovan, Ph.D
714-961-4483
Manufacturer Reason
for Recall		Test results may have incorrect ranges. If a default sample type setting on the tests screen is changed while running Unicel DXI system software version 4.3, the new setting is not saved to the system database. The changed sample type setting will reset to the previously saved setting when power is interrupted to the system, or if an operator reboots the system. If the default sample type i
FDA Determined
Cause 2		Software design
ActionBeckman Coulter forwarded on 7/6/10 a Product Corrective Action letter with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the UniCel Dxl 600 and Dxl 800 Access Immunoassay systems. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to: A revised version of UniCel DxI System Software that corrects this issue is currently in development. Until the new software version is available, Beckman Coulter has provided an alternate method for changing the default sample type setting. See the appendix included with this letter for additional information. Refer to the attached Questions and Answers document for additional details and instructions, and to determine if their laboratory is running UniCel DxI Sytem Software version 4.3. Customers may wish to confirm that proper ranges and units of measure are being reported for any Access assays with sample type settings that were changed while running software version 4.3. Customers were asked to share this information with their laboratory staff, and retain the notification as part of their laboratory Quality Ststem documentation. Complete and return the enclosed response form within 10 days so Beckman Coulter can be assured that consignees received the notification. If they need assistance or have any questions regarding this notification, customers were told to contact Technical Support at 1-800-854-3633 in the United States or Canada. Outside the United States and Canada, contact your local Beckman Coulter Representative.
Quantity in Commerce626 units
DistributionNationwide in the US and to Canada
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = JJE
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