Class 2 Device Recall DxA 5000 (DxA Automation System, DxA 5000 Fit)

• Date Initiated by Firm: June 02, 2023
• Date Posted: July 14, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2144-2023
• Recall Event ID: 92484
• 510(K)Number: K190298
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
• Code Information: UDI-DI: (01)15099590707118, All DxA serial numbers
• Recalling Firm/ Manufacturer: Beckman Coulter Biomedical GmbH; Sauerbruchstr. 50; Munchen Germany
• Manufacturer Reason for Recall: A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results
• FDA Determined Cause: Software design
• Action: On 06/12/2023, Beckman Coulter issued an Urgent Medical Device Recall Notification to affected consignees. Beckman Coulter asked consignees to take the following actions: 1. Inspect tubes routed to error regions and confirm that the tube type was appropriate per the assay IFU for the test performed. 2. 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. 3. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: " Electronically, if you received this communication via email./" Manually, complete and return the enclosed Response Form. 4. If you have any questions regarding this notice, please contact our Customer Support Center or your local Beckman Coulter Representative: " From our website: http://www.beckmancoulter.com/" By phone: call 1-800-526-3821 in the United States. 5. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
• Quantity in Commerce: 146 systems
• Distribution: US: AL CA FL IL IN KY MI MN MO NE NJ NV NY OH PA SC TX WI WV OUS: Australia, Belgium, Canada, China, Croatia, Czechia, Egypt, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Malaysia, Netherlands, New Zealand, Poland, Saudi Arabia, Spain, Switzerland, 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 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