JGQClass II

Turbidimetric, Total Protein

Clinical Chemistry · 21 CFR 862.1635

MDR events41All time

Recalls1All time

Registered firms11Currently listed

510(k) clearances13All time

Recent MDR events

41 adverse event reports on file

Event type breakdown

Malfunction41

Most-reported manufacturers

Roche Diagnostics39 Beckman Coulter Biomedical Ireland Limited1 Orthoclinical Diagnostics1

Recalls

1 recall events for this product code

Siemens Healthcare Diagnostics, Inc.
TerminatedOct 17, 2013
Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent Cartridge Lot 11349BB
Siemens has confirmed an increase on absorbance errors when calibrating Dimension Vista Urinary/Cerebrospinal Fluid Protein (U CFP) Flex Reagent Cartridge lot 11349 BB.
Z-0017-2014 · View FDA record ↗

Registered firms

11 firms currently registered for this product code

510(k) clearances

13 clearances for this product code