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Stratus® CS
Siemens Healthcare Diagnostics Inc. · Model 10444834 · UDI-DI 00842768024863
1
510(k) clearances
189
Adverse events
15
Recalls
31
Facilities
Description
The Stratus® CS STAT Fluorometric Analyzer is a microprocessor controlled instrument that measures analytes in body fluids for in vitro diagnostic use. The instrument is intended for use by trained healthcare professionals in the clinical laboratory and point of care settings and is intended for the measurement of the following analytes: High Sensitivity Troponin-I (CTNI), CK-MB Mass (Creatine kinase. MB) (CKMB), Myoglobin (MYO), NT-proBNP (PBNP), D-dimer (DDMR), CardioPhase hsCRP (High Sensitiv
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-31 | Siemens Healthcare Diagnostics Inc | Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IVD test for cardiac troponin I in heparinized plasma by removal. The reason for the |
| 2018-04-30 | Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc | A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused leakage through the pinhole. If the cartridge with leakage is used, higher measurement |
| 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. |
| 2016-06-22 | Siemens Healthcare Diagnostics Inc | Software defect, where either an Above Assay Range or an inaccurate value could potentially be reported, in the Stratus CS Acute Care Diagnostics System regarding TestPak calibrati |
| 2015-11-11 | Siemens Healthcare Diagnostics Inc | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems |
| 2015-11-11 | Siemens Healthcare Diagnostics Inc | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems |
| 2012-01-25 | Siemens Healthcare Diagnostics | Siemens Healthcare Diagnostics has observed that the median for the reference range with current kit lots of the CK-MB assay differs from the guidelines published in the Instructio |
| 2012-01-25 | Siemens Healthcare Diagnostics | Siemens Healthcare Diagnostics has observed that the median for the reference range with current kit lots of the CK-MB assay differs from the guidelines published in the Instructio |
| 2012-01-25 | Siemens Healthcare Diagnostics | Siemens Healthcare Diagnostics has observed that the median for the reference range with current kit lots of the CK-MB assay differs from the guidelines published in the Instructio |
| 2012-01-25 | Siemens Healthcare Diagnostics | Siemens Healthcare Diagnostics has observed that the median for the reference range with current kit lots of the CK-MB assay differs from the guidelines published in the Instructio |
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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.