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DImension Vista® Haptoglobin Flex® reagent cartridge

Siemens Healthcare Diagnostics Products GmbH · Model 10445896 · UDI-DI 00842768006111

DAD
10
510(k) clearances
1
Adverse events
1
Recalls
31
Facilities

Description

For the quantitative measurement of haptoglobin in human serum and plasma on the Dimension Vista® System

Recalls

DateFirmReason
2018-05-16Abbott Laboratories, IncAn 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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Data 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.