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Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge
Siemens Healthcare Diagnostics Inc. · Model 10444904 · UDI-DI 00842768013829
1
510(k) clearances
52
Adverse events
2
Recalls
11
Facilities
Description
Mass Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 160 tests
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-01-02 | Siemens Healthcare Diagnostics, Inc. | Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirol |
| 2010-12-22 | BioCheck Inc | Product labels indicate that the products are for IVD use and they do not have an approved 510(k). |
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