Home › Siemens Healthcare Diagnostics Inc. › Dimension Vista® Flex® reagent cartridge MMB
Dimension Vista® Flex® reagent cartridge MMB
Siemens Healthcare Diagnostics Inc. · Model 10445097 · UDI-DI 00842768015328
1
510(k) clearances
51
Adverse events
2
Recalls
11
Facilities
Description
Mass Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 100 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). |
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.