Home › Device types › JHS
Differential Rate Kinetic Method, Cpk Or Isoenzymes
FDA product code JHS · Class 2 · Clinical Chemistry
23
Registered devices
158
Adverse events
11
Recalls
38
510(k) clearances
Devices with this code
VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.Atellica IM CKMB — Siemens Healthcare Diagnostics Inc.VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.ADVIA Centaur® Systems, ACS:180® Systems CKMB Calibrator — Siemens Healthcare Diagnostics Inc.Atellica IM CKMB — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® CKMB Diluent — Siemens Healthcare Diagnostics Inc.CKL Creatine Kinase — Roche Diagnostics GmbHAtellica IM CKMB Calibrator — Siemens Healthcare Diagnostics Inc.Atellica IM CKMB — Siemens Healthcare Diagnostics Inc.Creatine Kinase — Roche Diagnostics GmbHDimension Vista® Flex® reagent cartridge MBI — Siemens Healthcare Diagnostics Inc.Creatine Kinase — Roche Diagnostics GmbHCreatine kinase — Roche Diagnostics GmbHADVIA Centaur® CKMB — Siemens Healthcare Diagnostics Inc.Creatine Kinase — Roche Diagnostics GmbHVITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.Creatine KinaseMB — Roche Diagnostics GmbHCreatine KinaseMB — Roche Diagnostics GmbHAtellica IM CKMB DIL — Siemens Healthcare Diagnostics Inc.CKMB UDR — SENTINEL CH. SPAVITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.Dimension® Flex® reagent cartridge CKI — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® CKMB — Siemens Healthcare Diagnostics Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-15 | Roche Diagnostics Operations, Inc. | Creatine Kinase (CK) Assay Abnormal calibrations on the cobas c 311/501/502 and COBAS INTEGRA 400 plus Analyzers may lead to erroneous results and misdiagnosis. |
| 2020-12-11 | Ortho Clinical Diagnostics Inc | VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference |
| 2020-04-01 | Ortho-Clinical Diagnostics | The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results. |
| 2020-04-01 | Ortho-Clinical Diagnostics | The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results. |
| 2018-07-24 | Siemens Healthcare Diagnostics, Inc | A potential bias was identified with certain kits compared to the internal standards. |
| 2018-07-24 | Siemens Healthcare Diagnostics, Inc | A potential bias was identified with certain kits compared to the internal standards. |
| 2018-07-24 | Siemens Healthcare Diagnostics, Inc | A potential bias was identified with certain kits compared to the internal standards. |
| 2018-07-24 | Siemens Healthcare Diagnostics, Inc | A potential bias was identified with certain kits compared to the internal standards. |
| 2018-07-24 | Siemens Healthcare Diagnostics, Inc | A potential bias was identified with certain kits compared to the internal standards. |
| 2013-06-12 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
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