JIQClass I

Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.)

Clinical Chemistry · 21 CFR 862.1645

MDR events20All time

Recalls1All time

Registered firms21Currently listed

510(k) clearances13All time

Recent MDR events

20 adverse event reports on file

Event type breakdown

Malfunction18

Injury2

Most-reported manufacturers

Roche Diagnostics15 Abbott Gmbh2 Beckman Coulter Inc.1 Em Science, Div. Em Industries Inc.1 Kendall Mcgaw1

Recalls

1 recall events for this product code

HemoCue AB
TerminatedDec 28, 2012
Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its inner walls. The urine
Incorrect version of Quick Reference Guide (QRG) was delivered with products in shipment made from April1 st 2011 and onwards. In addition, a warranty statement was missing in the analyzer package.
Z-0619-2013 · View FDA record ↗

Registered firms

21 firms currently registered for this product code

510(k) clearances

13 clearances for this product code