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Syva® Emit® 2000 Sirolimus Assay
Siemens Healthcare Diagnostics Inc. · Model 10445401 · UDI-DI 00842768029615
1
510(k) clearances
33
Adverse events
6
Recalls
6
Facilities
Description
Syva® Emit® 2000 Sirolimus Assay
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 2017-06-29 | Siemens Healthcare Diagnostics, Inc. | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely ele |
| 2016-02-09 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has received customer complaints regarding QC shifts and imprecision after one day when using Dimension SIRO lot EB6064. They have confirmed SIRO lot |
| 2010-05-27 | Abbott Laboratories | The Architect Sirolimus assay lot 80162M100 is exhibiting higher than normal reports of barcode read errors. |
| 2010-04-30 | Abbott Laboratories | IMx Sirolimus reagent lot 802873106 has exhibited an increased frequency of calibration errors. |
| 2006-08-11 | Abbott Laboratories MPG | The sirolimus values may shift higher after storage at 2-8C or after one freeze/thaw cycle of specimens. |
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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.