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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80535

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
June 22, 2018
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Clarity Diagnostics Llc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

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Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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
Recall number
Z-2786-2018
Initiated
June 22, 2018
Classification
Class III
Status
Terminated
Recalling firm
Clarity Diagnostics Llc
Quantity
7536 Bottles

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

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Inspect official wording and provenance

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.

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.