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Access CEA Calibrators
Beckman Coulter, Inc. · Model 33205 · UDI-DI 15099590624835
DHX
Prescription
1
510(k) clearances
308
Adverse events
9
Recalls
27
Facilities
Description
The Access CEA Calibrators (BSA matrix) are intended to calibrate the Access CEA assay for the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum, using the Access Immunoassay Systems.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-03-05 | Tosoh Bioscience Inc | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. |
| 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 |
| 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 |
| 2015-10-13 | Beckman Coulter Inc. | Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly. |
| 2010-12-22 | BioCheck Inc | Product labels indicate that the products are for IVD use and they do not have an approved 510(k). |
| 2006-04-12 | Beckman Coulter Inc | Firm has confirmed that the Access CEA Assay may generate decreased values with certain frozen platelet specimens. |
| 2005-05-26 | Diagnostic Products Corp | Adverse trend in stability, controls biased or out of range. |
| 2004-05-03 | Diagnostic Products Corp | Instabililty |
| 2003-12-03 | Ortho-Clinical Diagnostics | Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results. |
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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.