Home › Siemens Healthcare Diagnostics Inc. › Stratus® CS Acute Care™ CCRP TestPak
Stratus® CS Acute Care™ CCRP TestPak
Siemens Healthcare Diagnostics Inc. · Model 10445066 · UDI-DI 00842768004469
1
510(k) clearances
189
Adverse events
15
Recalls
31
Facilities
Description
The Stratus® CS Acute Care™ CardioPhase® high sensitivity CRP method (hsCRP) is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in lithium and sodium heparin plasma and is intended to be used on the Stratus® CS analyzer.
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.