FDA Device Intelligence
Home › Roche Diagnostics GmbH › Protein Total Protein in UrineCerebrospinal Fluid

Protein Total Protein in UrineCerebrospinal Fluid

Roche Diagnostics GmbH · Model 11877801160 · UDI-DI 04015630936441

JGQ Prescription
10
510(k) clearances
41
Adverse events
1
Recalls
8
Facilities

Recalls

DateFirmReason
2012-12-19Siemens Healthcare Diagnostics, Inc.Siemens has confirmed an increase on absorbance errors when calibrating Dimension Vista Urinary/Cerebrospinal Fluid Protein (U CFP) Flex Reagent Cartridge lot 11349 BB.

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 docs
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.