CDMClass I

Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.)

Clinical Chemistry · 21 CFR 862.1785

MDR events21All time

Recalls1All time

Registered firms126Currently listed

510(k) clearances9All time

Recent MDR events

21 adverse event reports on file

COBAS U PACK (400 STRIPS)Jul 13, 2026
MalfunctionRoche Diagnostics1823260-2026-02827
COBAS U PACK (400 STRIPS)Aug 27, 2025
MalfunctionRoche Diagnostics1823260-2025-02627
MEDLINE URINALYSIS REAGENT STRIPSJun 5, 2025
InjuryAcon Laboratories, Inc.2531491-2025-00121
HEMASTIXMay 26, 2025
MalfunctionSiemens Healthcare Diagnostics Inc.3002637618-2025-00038
HEMA-COMBOSTIX®Jul 22, 2024
MalfunctionSiemens Healthcare Diagnostics Inc.3002637618-2024-00076
URISPEC 10SG URINE STRIPSJun 21, 2023
MalfunctionAcon Laboratories, Inc.2531491-2023-00612
ROCHE CHEMSTRIP 7Apr 29, 2022
MalfunctionRoche Diagnostics / Roche Diagnostics International Ltd.MW5109456
MCKESSON CONSULT U120 URINE ANALYZERSep 17, 2018
MalfunctionAcon Laboratories, Inc.7881844
ICHEMVELOCITY URINE CHEMISTRY SYSTEMMar 17, 2017
MalfunctionIris International, Inc.6413119
ICHEM VELOCITYApr 6, 2015
MalfunctionIris International2023446-2015-00114

Event type breakdown

Malfunction16

Other4

Injury1

Most-reported manufacturers

Iris International4 Acon Laboratories, Inc.3 Roche Diagnostics2 Siemens Healthcare Diagnostics2 Siemens Healthcare Diagnostics Inc2 Siemens Healthcare Diagnostics Inc.2 Ark Ray Usa Inc.1 Hypoguard1

Recalls

1 recall events for this product code

Clarity Diagnostics Llc
TerminatedJul 24, 2018
Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG
Clarity Diagnostics LLC discovered specific lots of Clarity 10SG Strips are not compatible for use in the Clarity Urocheck 120 Urine Analyzers, due to lack of Canister Code Bar Code Label.
Z-2786-2018 · View FDA record ↗

Registered firms

126 firms currently registered for this product code

510(k) clearances

9 clearances for this product code