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Uristix® Reagent Strips

Siemens Healthcare Diagnostics Inc. · Model 10339520 · UDI-DI 00630414549132

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510(k) clearances

Adverse events

Recalls

Facilities

Description

Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein and glucose.

Recalls

Date	Firm	Reason
2018-06-22	Clarity Diagnostics Llc	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 Co

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.