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Recall Observatory FDA recall evidence

Device 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.

Z-2786-2018

June 22, 2018

Class III

Product summary

Firm
Clarity Diagnostics Llc
Event
Event 80535
Status
Terminated
Classification
Class III
Quantity
7536 Bottles
Official record key
device-enforcement:Z-2786-2018

Official wording

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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.