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Axis-Shield Active-B12 (Holotranscobalamin) EIA
AXIS-SHIELD DIAGNOSTICS LIMITED · Model FMABT100 · UDI-DI 05055845400046
CDD
Prescription
1
510(k) clearances
356
Adverse events
12
Recalls
31
Facilities
Description
The Axis-Shield Active-B12 (Holotranscobalamin) assay is an enzyme-immunoassay (EIA) for the quantitative determination of holotranscobalamin (HoloTC) in human serum. HoloTC (vitamin B12 bound to transcobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency.
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 erroneously low or hi |
| 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 centrifuge. This detac |
| 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 centrifuge. This detac |
| 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 centrifuge. This detac |
| 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 confuse the bar codes wi |
| 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 MMB, Dimension Sirol |
| 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 elevation in the reporte |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.