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Dimension Vista®a1-Antitrypsin Flex® reagent cartridge
Siemens Healthcare Diagnostics Products GmbH · Model 10445884 · UDI-DI 00842768005992
1
510(k) clearances
5
Adverse events
1
Recalls
23
Facilities
Description
For the quantitative measurement of a1-antitrypsin in human serum and plasma on the Dimension Vista® System
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-08-23 | The Binding Site Group, Ltd. | The high control for the kit is recovering low and may be out of range for assigned values. |
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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.