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Elecsys CA 125 II
Roche Diagnostics GmbH · Model 09755586190 · UDI-DI 07613336218327
LTK
Prescription
1
510(k) clearances
228
Adverse events
8
Recalls
30
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-02-21 | Siemens Healthcare Diagnostics, Inc | Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use. |
| 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 |
| 2013-10-09 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products CA 125 II Reagent Pack and Calibrators due to a positive shift in patient r |
| 2010-12-22 | BioCheck Inc | Product labels indicate that the products are for IVD use and they do not have an approved 510(k). |
| 2010-12-22 | BioCheck Inc | Product labels indicate that the products are for IVD use and they do not have an approved 510(k). |
| 2010-12-14 | Siemens Healthcare Diagnostics, Inc | Positive bias (40-55%) with patient results greater than the upper limit of normal and less than the upper limit of normal |
| 2007-04-23 | Abbott Laboratories | Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent k |
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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.