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Creatine Kinase
Roche Diagnostics GmbH · Model 08057460190 · UDI-DI 07613336121122
JHS
Prescription
1
510(k) clearances
158
Adverse events (1 deaths)
11
Recalls
10
Facilities
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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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.