Product Wiki · Recalls · U.S. FDA — Device Enforcement

Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urinalysis Reagent Strips (Urine) are for the qualitative and semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, — recall Z-2786-2018

U.S. FDA — Device Enforcement · United States · 2018-06-22 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2786-2018
Date of alert
2018-06-22
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Clarity Diagnostics Llc
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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