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Elecsys CA 15-3 II
Roche Diagnostics GmbH · Model 09755594190 · UDI-DI 07613336218334
MOI
Prescription
1
510(k) clearances
208
Adverse events
18
Recalls
25
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-07-18 | Siemens Healthcare Diagnostics, Inc. | Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and management decisions. |
| 2021-07-06 | Siemens Healthcare Diagnostics, Inc | Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and futur |
| 2021-07-06 | Siemens Healthcare Diagnostics, Inc | Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and futur |
| 2021-07-06 | Siemens Healthcare Diagnostics, Inc | Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and futur |
| 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 |
| 2017-04-13 | Beckman Coulter Inc. | Following biases observed in the results of the French National Quality Controls, Beckman Coulter has been informed that a study completed by the French Competent Authority Agence |
| 2017-03-08 | Siemens Healthcare Diagnostics, Inc | Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems |
| 2017-03-08 | Siemens Healthcare Diagnostics, Inc | Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems |
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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.