FDAFDA · Food and drugs·Recall number Z-2414-2024
Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
Published July 31, 2024 · Recall initiated: June 4, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Beckman Coulter, Inc.
- Distributor
- 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.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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