Boca Raton, FL, United States
Clarity Diagnostics Llc recalls
1 recall recorded since 2018, most recently on 22 June 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class III Medical devices
- Recall started
- 22 June 2018
- Terminated
- 12 January 2024
- Reason
- 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.
- Distribution
- Worldwide Distribution - US Nationwide in the states of AZ, MA, SC, WA. and the country of Austria.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2786-2018
- 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: Gluc
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.