Reported Aug 22, 2018 · Terminated
Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urinalysis Reagent Strips (Urine)…
Clarity Diagnostics LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Clarity Diagnostics Llc · 1060 Holland Dr Ste A · Boca Raton, FL · 33487-2758
Is this the product you have?
- Clarity Urocheck 10SG Urinalysis Strips, Model #
- DTG-10SG Product UsageClarity 10SG Urinalysis Reagent Strips (Urine) are for the qualitative and semi-quantitative detection
- of the following analytes in urineGlucose, 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 areaskidney 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
- Lot codes and dates
- Model # DTG-10SG
- Lot Codes
URS7100027EXURS7100140EX and URS8010016EX
- Amount recalled
- 7536 Bottles
Where it was sold
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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