Home › Siemens Healthcare Diagnostics Products GmbH › DImension Vista® C1 Inhibitor Flex® Reagent Cartridge
DImension Vista® C1 Inhibitor Flex® Reagent Cartridge
Siemens Healthcare Diagnostics Products GmbH · Model 10445915 · UDI-DI 00842768006302
1
510(k) clearances
0
Adverse events
1
Recalls
5
Facilities
Description
For the quantitative measurement of C1 inhibitor in human serum and plasma on the Dimension Vista® System
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-02-01 | Quidel Corporation | Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert. |
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.