Clarity Diagnostics Llc: 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, Urobilinogen, Nitrite and Leukocytes. The Clarity Urinalysis Reagent Strips (Urine) are for single use in professional near-patient (point-of-care) and centralized laboratory locations, and are intended for professional use only. The strips are intended for use in screening at-risk patients to assist diagnosis in the following areas: kidney function, urinary tract infections, carbohydrate metabolism (e.g. diabetes mellitus), liver function, acid-base balance and urine concentration. The results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed. The Clarity 10SG Urinalysis Reagent Strips (Urine) can be read visually , on the Clarity Urocheck 120 Urine Analyzers , and on the Clarity Urocheck 120C Urine Analyzers.

Recall number

Z-2786-2018

Recalling firm

Clarity Diagnostics Llc

Product

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, Urobilinogen, Nitrite and Leukocytes. The Clarity Urinalysis Reagent Strips (Urine) are for single use in professional near-patient (point-of-care) and centralized laboratory locations, and are intended for professional use only. The strips are intended for use in screening at-risk patients to assist diagnosis in the following areas: kidney function, urinary tract infections, carbohydrate metabolism (e.g. diabetes mellitus), liver function, acid-base balance and urine concentration. The results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed. The Clarity 10SG Urinalysis Reagent Strips (Urine) can be read visually , on the Clarity Urocheck 120 Urine Analyzers , and on the Clarity Urocheck 120C Urine Analyzers.

Status

Terminated

Initiated

2018-06-22

Posted

2018-07-24

Terminated

2024-01-12

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.

Root cause

Labeling design

Action

The firm notified the major distributor who received this product on or about 06/14/2018 via a letter entitled "URGENT: Voluntary Medical Device Recall for Clarity 10SG Urinalysis Reagent Strips". The distributor letter stated effective immediately, the purpose of this letter is to advise that Clarity Diagnostics LLC is voluntarily recalling Clarity 10SG Strips Lot# URS7100027EX, Exp:11/2019 , URS7100140EX, Exp:11/2019 and URS8010016EX, Exp: 03/2020. The affected lots are not compatible for use in the Clarity Urocheck 120 Urine Analyzers which is why the recall is being performed. The letter also stated to ensure that communication is relayed to Clarity Diagnostics customers. Once the three lots have been secured, Clarity Diagnostics will follow up with the distributor regarding the disposal of the product. Clarity Diagnostics provided a telephone number for any customer concerns. Clarity Diagnostics has taken appropriate steps to assure that this problem will not reoccur in the future. Clarity Diagnostics also provided a letter to the distributor on or about 06/22/2018 entitled "URGENT PRODUCT RECALL". This letter was provided for distributor to notify its customers. This letter provided notification of a product recall regarding specific lots of Clarity Diagnostics - 10SG Urinalysis Reagent Strips. This notice has been issued because the affected lots are not compatible for use in the Clarity Urocheck 120 Urine Analyzers. Affected product first shipped April 5, 2018. Questions can be directed to the Clarity Diagnostics individual handing the recall---Ashish Parikh at Clarity Diagnostics (877) 722-6339.

Quantity

7536 Bottles

Distribution

Worldwide Distribution - US Nationwide in the states of AZ, MA, SC, WA. and the country of Austria.

Lot, serial or model codes

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

510(k) numbers

["K061559"]

PMA numbers

not on file

Product code

CDM

Firm FEI

3004043187

Firm city

Boca Raton

Firm state

FL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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