—#208494

Product

Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K221225
Affected lot / code info: 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.

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter, Inc.
Address: 1000 Lake Hazeltine Dr, Chaska, Minnesota 55318-1037

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2024-06-04
Posted by FDA: 2024-07-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208494. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.