Home › Device types › NRP
Sirolimus Test System
FDA product code NRP · Class 2 · Clinical Toxicology
10
Registered devices
33
Adverse events
6
Recalls
5
510(k) clearances
Devices with this code
Alinity-Architect — ABBOTT LABORATORIESSyva® Emit® 2000 Sirolimus Assay — Siemens Healthcare Diagnostics Inc.Syva® Emit® 2000 Siro/Tacro Sample Pretreatment Reagent — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott Ireland DiagnosticsAlinity — Abbott Ireland DiagnosticsARCHITECT — ABBOTT LABORATORIESAlinity — Abbott Ireland DiagnosticsARCHITECT — Abbott Ireland DiagnosticsDimension® Flex® reagent cartridge SIRO — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott Ireland Diagnostics
Recent 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 |
| 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 |
| 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 hav |
| 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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