Home › Device types › CDD
Radioassay, Vitamin B12
FDA product code CDD · Class 2 · Clinical Chemistry
63
Registered devices
356
Adverse events
12
Recalls
78
510(k) clearances
Devices with this code
Atellica IM Calibrator C — Siemens Healthcare Diagnostics Inc.Alinity — Abbott GmbHADVIA Centaur® Calibrator C — Siemens Healthcare Diagnostics Inc.AIA-PACK B12 Calibrator Set — TOSOH CORPORATIONAtellica IM VB12 DTT/REL — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® VB12 DTT/Releasing Agent — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott GmbHIMMULITE®/IMMULITE® 1000 Systems VB Vitamin B12 Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDFolate, Vit B12 Anemia Panel AccuBind VAST ELISA Test System - 96 Wells — MONOBIND, INC.Access Vitamin B12 — Beckman Coulter, Inc.VITROS — ORTHO CLINICAL DIAGNOSTICSElecsys Vitamin B12 II — Roche Diagnostics GmbHADVIA Centaur® VB12 — Siemens Healthcare Diagnostics Inc.Elecsys Vitamin B12 II — Roche Diagnostics GmbHAlinity — ABBOTT IRELANDMonobind AccuLite Folate & Vit B12 VAST CLIA Kit - 192 Wells — MONOBIND, INC.ADVIA Centaur® CKMB MCM — Siemens Healthcare Diagnostics Inc.Atellica IM VB12 — Siemens Healthcare Diagnostics Inc.Folate, Vit B12 Anemia Panel AccuBind VAST ELISA Test System - 192 Wells — MONOBIND, INC.Dimension Vista® Flex® reagent cartridge VB12 — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott GmbHARCHITECT — ABBOTT IRELANDIMMULITE®/IMMULITE® 1000 Systems VB Vitamin B12 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDADVIA Centaur® Calibrator C — Siemens Healthcare Diagnostics Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-02-27 | Beckman Coulter, Inc. | Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitamin B12 Reagent lot 439850. The affected reagent lot may cause e |
| 2024-07-17 | Beckman Coulter Biomedical GmbH | The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the ce |
| 2024-07-17 | Beckman Coulter Biomedical GmbH | The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the ce |
| 2024-07-17 | Beckman Coulter Biomedical GmbH | The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the ce |
| 2021-07-28 | Beckman Coulter Inc. | Missing splash guard which may expose users to hazardous materials. . |
| 2019-11-15 | Tosoh Smd Inc | The AIA-2000 bar code scanners depend on the quiet zone to help identify the bar code. The lack of an adequate quiet zone can cause the bar code scanner to conf |
| 2018-11-30 | Tosoh Bioscience Inc | Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays |
| 2018-08-28 | Ortho-Clinical Diagnostics | The reagent pack exhibits the potential for an increased frequency of calibration failures. |
| 2018-01-02 | Siemens Healthcare Diagnostics, Inc. | Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista |
| 2012-05-08 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has confirmed that the presence of Intrinsic Factor Blocking Antibody in some patients can result in a false and significant elev |
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