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Dimension Vista® C4 Complement Flex® reagent cartridge
Siemens Healthcare Diagnostics Products GmbH · Model 10445891 · UDI-DI 00842768006067
1
510(k) clearances
1
Adverse events
2
Recalls
32
Facilities
Description
For the quantitative measurement of C4 complement in human serum and plasma on the Dimension Vista® System
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-08-27 | Roche Diagnostics Operations, Inc. | Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the re |
| 2018-05-16 | Abbott Laboratories, Inc | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products. |
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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.