FDAClass IIIAugust 22, 2018

Clarity Urocheck 10SG Urinalysis Strips recall

Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urinalysis Reagent Strips (Urine) are for the qualitative and…

Why was Clarity Urocheck 10SG Urinalysis Strips recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model # DTG-10SG; Lot Codes: URS7100027EX , URS7100140EX and URS8010016EX.

Product
Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urinalysis Reagent Strips (Urine) are for the qualitative and…
Recalling firm
Clarity Diagnostics Llc
Quantity
7536 Bottles
Distribution
Worldwide Distribution - US Nationwide in the states of AZ, MA, SC, WA. and the country of Austria.
Recall date
August 22, 2018
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls