Recall Z-2786-2018 ยท CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
Clarity Diagnostics Llc
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
| Date | Jul 24, 2018 (initiated Jun 22, 2018) |
| Status | Terminated |
| 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. |
| Root cause | Labeling design |
| Action | The firm notified the major distributor who received this product on or about 06/14/2018 via a letter entitled "URGENT: Voluntary Medical Device Recall for Clarity 10SG Urinalysis Reagent Strips". The distributor letter stated effective immediately, the purpose of this letter is to advise that Clarity Diagnostics LLC is voluntarily recalling Clarity 10SG Strips Lot# URS7100027EX, Exp:11/2019 , URS7100140EX, Exp:11/2019 and URS8010016EX, Exp: 03/2020. The affected lots are not compatible for use in the Clarity Urocheck 120 Urine Analyzers which is why the recall is being performed. The lette |
| Quantity | 7536 Bottles |
| Distribution | Worldwide Distribution - US Nationwide in the states of AZ, MA, SC, WA. and the country of Austria. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061559 | ACON URINALYSIS REAGENT STRIPS Acon Laboratories Co., Aug 11, 2006 |