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U.S. Department of Health and Human Services

Class 2 Device Recall UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems

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  Class 2 Device Recall UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems see related information
Date Initiated by Firm December 05, 2018
Date Posted March 30, 2019
Recall Status1 Open3, Classified
Recall Number Z-1078-2019
Recall Event ID 82079
510(K)Number K042291  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system is separated from the DxC system and the DxI instrument is then connected to an automation line.

System Name/ Catalog Number:
DxC 660i/ A64871,
DxC 680i /A64903,
DxC 860i /A64935,
DxC 880i /A59102
Code Information Systems running software versions: 5.2, 5.3.0, 5.3.1.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact David Davis
305-380-2604
Manufacturer Reason
for Recall		 When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandling of samples during the creation of an aliquot and lead to incorrect results being generated. Affected samples typically yield non-reproducible falsely decreased results by up to 100%, however the potential for falsely elevated results cannot be ruled out.
FDA Determined
Cause 2		 Under Investigation by firm
Action On 12/05/18, the firm mailed Urgent Medical Device Recall notices to all consignees. In order to prevent this error from occurring, do not load racks onto the SPU while samples are being processed from the automation line. Either of the following options can be followed to avoid the error: 1) Pause the automation line before loading of any racks onto the SPU. a) To pause the automation line and load racks on the SPU, use the following steps: i) Set the Lab Automation System (LAS) Mode to "Offline" (1) Return to the Main Menu (F9) (2) Select Configure (F8) (3) Select LIS/LAS (F6) (4) Select LAS (F2) (5) In the dropdown menu, select "Offline" and press OK (F1) ii) Load samples onto the SPU iii) Wait until all racks from the SPU are fully aspirated and moved to the off-load area b) To resume processing using the automation line, follow Step (i) above and select "Online" from the dropdown menu. 2) As an alternative to pausing automation line operation, racks can be loaded onto the SPU of any stand-alone instrument (if available). - Interpret results in light of the total clinical presentation of the patient including: symptoms, clinical history, data from additional tests, and other appropriate information. - Review this letter with your Medical Director to determine if any further actions are warranted, including a review of results previously generated by affected systems. The firm will implement a correction in the next software release. Your service representative will contact you to schedule your software upgrade when available. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter. Customers were asked to complete and return the Response Form. Customers with additional questions were encouraged to call:1-800-854-363
Quantity in Commerce 0
Distribution US: NJ, OH, NY, GA, FL, TN, WI, MI, MS, CA, NC, TX, PA, DC, IN, KY, IL, WA, MN, LA, ND, ID, WV, AK, AL, MA. OUS: Argentina, Australia, Bahrain, Canada, China, Croatia, Czech Republic, Egypt, Germany, Greece, India, Italy, Malaysia, Morocco, Netherlands, Nigeria, Poland, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Thailand, Tunisia, United Kingdom, United States, Vietnam
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = BECKMAN COULTER, INC.
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