Home › Device types › JHX
Fluorometric Method, Cpk Or Isoenzymes
FDA product code JHX · Class 2 · Clinical Chemistry
45
Registered devices
189
Adverse events
15
Recalls
48
510(k) clearances
Devices with this code
Stratus CS Acute Care CCRP CalPak — Siemens Healthcare Diagnostics Inc.PATHFAST CK-MB-II — PHC CORPORATIONStratus® CS Acute Care™ cTNI TestPak — Siemens Healthcare Diagnostics Inc.Stratus® CS Acute Care™ cTNI DilPak — Siemens Healthcare Diagnostics Inc.AIA-PACK CK-MB Sample Diluting Solution — TOSOH CORPORATIONStratus® CS STAT Fluorometric Analyzer Sample Cups — Siemens Healthcare Diagnostics Inc.Thermo Scientific — Fisher DiagnosticsARCHITECT — Abbott Ireland DiagnosticsTriage — QUIDEL CARDIOVASCULAR INC.Alere Triage® — Alere San Diego, Inc.RAMP® CK-MB TEST KIT; 25 TESTS — Response Biomedical CorpAlere Triage® — Alere San Diego, Inc.Stratus® CS STAT Fluorometric Analyzer Rotors — Siemens Healthcare Diagnostics Inc.Alere Triage® — Alere San Diego, Inc.VIDAS® CK-MB — BIOMERIEUX SAST AIA-PACK CK-MB — TOSOH CORPORATIONTriage — QUIDEL CARDIOVASCULAR INC.ARCHITECT — Abbott Ireland DiagnosticsTriage — QUIDEL CARDIOVASCULAR INC.VITROS — ORTHO CLINICAL DIAGNOSTICSAccess CK-MB — Beckman Coulter, Inc.Stratus® CS Acute Care™ MYO TestPak — Siemens Healthcare Diagnostics Inc.Stratus® CS Acute Care™ CKMB TestPak — Siemens Healthcare Diagnostics Inc.Stratus® CS Acute Care™ CKMB CalPak — Siemens Healthcare Diagnostics Inc.
Recent 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. |
| 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 |
| 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, dependin |
| 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 regardi |
| 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 publish |
| 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 publish |
| 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 publish |
| 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 publish |
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