Z-2786-2018Class III

Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG

Name: Z-2786-2018 Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG
Creator: Clarity Diagnostics Llc
Published: 2018-06-22
License: https://open.fda.gov/license/

Clarity Diagnostics, LLC / initiated 2018-06-22 / Terminated / root cause: labeling and UDI

FDA source

Clarity Diagnostics Llc began a recall of Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urinalysis Reagent Strips (Urine) are for the qualitative and... on 2018-06-22. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2786-2018
Classification: Class III
Status: Terminated
Initiated: 2018-06-22
Posted: 2018-07-24
Terminated: 2024-01-12
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.
Product code: CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 7536 Bottles
Distribution: Worldwide Distribution - US Nationwide in the states of AZ, MA, SC, WA. and the country of Austria.
Product codes and lots: Model # DTG-10SG; Lot Codes: URS7100027EX , URS7100140EX and URS8010016EX.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2786-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2786-2018	Class III	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-11

Product code CDM

K061559Class IAcon Urinalysis Reagent StripsAcon Laboratories Co. / cleared 2006-08-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)