Class 2 Device Recall Dxl 9000 Access Immunoassay Analyzer

• Date Initiated by Firm: June 04, 2024
• Date Posted: July 23, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2414-2024
• Recall Event ID: 94847
• 510(K)Number: K221225
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
• Code Information: Serial numbers: 300117, 300116, 300137, 300138, 300139, 300129, 300141, 300143, 300142, 300151, 300152, 300128, 300156, 300153, 300154, 300135, 300164, 300180, 300155, 300167, 300166, 300158, 300171, 300179, 300169, 300182, 300176, 300183, 300198, 300192, 300133, 300188, 300161, 300134, 300190, 300209, 300212, 300211, 300149, 300148, 300150, 300130, 300172, 300197, 300160, 300189, 300170, 300181, 300195, 300194, 300224, 300222, 300168, 300210, 300233, 300207, 300205, 300221, 300203, 300240, 300199, 300200, 300136, 300196, 300178, 300220, 300208, 300126, 300213, 300206, 300219, 300214, 300217, 300215, 300229, 300255, 300257, 300202, 300254, 300223, 300258, 300259, 300218, 300201, 300234, 300237, 300249, 300260, 300238, 300243, 300261, 300231, 300191, 300131, 300236, 300264, 300263, 300193, 300239, 300230, 300235, 300245, 300216, 300247, 300242, 300226, 300270, 300271, 300269, 300174, 300251, 300241, 300232, 300204, 300227, 300228, 300256, 300266, 300281, 300282, 300253, 300244, 300272, 300246, 300145, 300123, 300147, 300297, 300157, 300275, 300284, 300286, 300248, 300273, 300252, 300144, 300146, 300165, 300177, 300173, 300250, 300268, and 300140; UDI-DI 15099590732103.
• FEI Number: 2122870
• Recalling Firm/ Manufacturer: Beckman Coulter, Inc.; 1000 Lake Hazeltine Dr; Chaska MN 55318-1037
• For Additional Information Contact: Rachel Davison; 714-993-5321
• Manufacturer Reason for Recall: The analyzers were built with nonconforming USB cables made with brass contacts instead of specified gold contacts. Brass contacts may corrode over time, leading to loss of internal instrument communication and delayed patient results.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Letters dated 5/29/2024 were issued via email and postal mail on 6/4/2024. The letter described the issue, the impact, and the action which was that the consignee's Beckman Coulter service representative will contact the consignee to replace parts affected by the issue. The firm will replace all affected USB 2.0 cables. The information in the letter is to be shared with the consignees laboratory staff and if the device has been forwarded to another laboratory, the consignee is requested to send them a copy of the letter. The consignee is requested to respond to the letter within 10 days either via email or by manually completing the enclosed Response Form.
• Quantity in Commerce: 143 devices
• Distribution: Worldwide - US Nationwide distribution in the states of FL, IN, KS, NH, PA, and TX. The countries of Australia, Austria, Belgium, Brazil, Croatia, Czechia, Egypt, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Switzerland, Taiwan, Province of China, and United Kingdom of Great Britain and Northern Ireland.
• 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