Class 2 Device Recall DxA 5000

• Date Initiated by Firm: June 17, 2020
• Create Date: September 18, 2020
• Recall Status: Terminated on August 24, 2022
• Recall Number: Z-2983-2020
• Recall Event ID: 85874
• 510(K)Number: K190298
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system.
• Code Information: Serial/Lot Number(s)/Software Version: all
• Recalling Firm/ Manufacturer: Beckman Coulter Biomedical GmbH; Sauerbruchstr. 50; Munich Germany
• Manufacturer Reason for Recall: The DxA 5000 instructions for use may be confusing regarding the re-use of sample IDs. Beckman Coulter has received complaints where the re-use of sample barcodes were not being detected by the system .
• FDA Determined Cause: Device Design
• Action: The Urgent Medical Device Recall letters were sent via first class mail on 06/19/20. The actions to be taken by consignees are as follows: Avoid Duplicate IDs; DO NOT Re-use Sample IDs As indicated in the DxA 5000 instructions for use, ensure that only unique sample barcode IDs are used. Be aware of the difference between duplicate sample IDs and the re-use of the same sample ID, as the instrument appropriately detects duplicates, but not re-used sample IDs. *Duplicate sample IDs are defined as samples with the same ID concurrently being run on the instrument. *Re-used sample IDs are defined as previously processed sample IDs that are then used for a new sample. Resolution: Improvements to the detection capability for patient samples using identical barcode IDs are being identified. Share the information with laboratory staff and retain the notification as part of the laboratory Quality System documentation. If any of the affected product has been forwarded to another laboratory, provide them a copy of the letter. If you are a centralized license holder, provide the other affected laboratories of your organization or association with a copy of the letter. For assurance that the important communication has been received, respond within 10 days in one of the following ways: *Electronically, if you received the communication via email. * Manually, complete and return the enclosed Response Form. For questions regarding the notice, contact via: website: http://www.beckmancoulter.com By phone: contact your local representative.
• Quantity in Commerce: 32 units
• Distribution: Worldwide distribution - US Nationwide distribution including in the states of Illinois, Ohio, Pennsylvania, and West Virginia. The countries of Australia, Canada, China, Czech Republic, France, Israel, Italy, Germany, Switzerland, Spain, Netherlands, and United Kingdom.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JJE