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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 18 Results
510(K) Number: K221225
 
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DxI 9000 Access Immunoassay Analyzer, Part Number C11137 2 10/21/2025 FEI # 2122870
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer C11137 2 06/20/2025 FEI # 2122870
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20 2 06/06/2025 FEI # 2122870
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20 2 06/05/2025 FEI # 2122870
Beckman Coulter, Inc.
Beckman Coulter DxI 9000 Access Immunoassay Analyzer 2 04/24/2025 FEI # 2122870
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for ... 2 04/04/2025 FEI # 2122870
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137. 2 03/17/2025 FEI # 2122870
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C2... 2 03/17/2025 FEI # 2122870
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137 2 03/12/2025 FEI # 2122870
Beckman Coulter, Inc.
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic ins... 2 02/06/2025 FEI # 2122870
Beckman Coulter, Inc.
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