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ARCHITECT
Abbott Ireland Diagnostics · Model 07K68-35 · UDI-DI 00380740112424
DHX
Prescription
10
510(k) clearances
308
Adverse events
9
Recalls
27
Facilities
Description
ARCHITECT CEA Reagent kit
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.