Clarity Diagnostics Llc: Medical Device Recall in 2018 - (Recall #: Z-2786-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 Classification:

Class III

Date Initiated: June 22, 2018

Date Posted: August 22, 2018

Recall Number: Z-2786-2018

Event ID: 80535

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.

Status: Terminated

Product Quantity: 7536 Bottles

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated