Home / Recalls / Beckman Coulter, Inc. / Z-2414-2024

Z-2414-2024 Class II Ongoing

Recalled by Beckman Coulter, Inc. — Chaska, MN

FDA device recall Z-2414-2024 was initiated by Beckman Coulter, Inc. on Jun 4, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 143 devices.

Recall Details

Product Type
Devices
Report Date
Jul 31, 2024
Initiation Date
Jun 4, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
143 devices

Product Description

Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.

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.

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.

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.

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-2414-2024
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by Beckman Coulter, Inc.

  • Z-0083-2027 Class II — DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i… (Sep 2, 2026)
  • Z-0084-2027 Class II — DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519… (Sep 2, 2026)
  • Z-2974-2026 Class II — Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5… (Jul 15, 2026)
  • Z-2973-2026 Class II — Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or… (Jul 15, 2026)
  • Z-2888-2026 Class II — REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed… (Jun 26, 2026)
  • Z-2889-2026 Class II — REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the… (Jun 26, 2026)
  • Z-1922-2026 Class II — Access Total T4 Calibrator, Catalog No. 33805 (Mar 16, 2026)
  • Z-1235-2026 Class II — CellMek SPS Sample Preparation System, REF: C44603, with software (Dec 23, 2025)
  • Z-1025-2026 Class II — Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260… (Nov 26, 2025)
  • Z-1026-2026 Class II — Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288… (Nov 26, 2025)

FDA data resources