Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urinalysis Reagent Strips (Urine)
FDA device recall Z-2786-2018 · posted 2018-07-24 · Terminated
Recall details
- Recalling firm
- Clarity Diagnostics Llc
- 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.
- Action taken
- 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 letter also stated to ensure that communication is relayed to Clarity Diagnostics customers. Once the three lots have been secured, Clarity Diagnostics will follow up with the distributor regarding the disposal of the product. Clarity Diagnostics provided a telephone number for any customer concerns. Clarity Diagnostics has taken appropriate steps to assure that this problem will not reoccur in the future. Clarity Diagnostics also provided a letter to the distributor on or about 06/22/2018 entitled "URGENT PRODUCT RECALL". This letter was provided for distributor to notify its customers. This letter provided notification of a product recall regarding specific lots of Clarity Diagnostics - 10SG Urinalysis Reagent Strips. This notice has been issued because the affected lots are not compatible for use in the Clarity Urocheck 120 Urine Analyzers. Affected product first shipped April 5, 2018. Questions can be directed to the Clarity Diagnostics individual handing the recall---Ashish Parikh at Clarity Diagnostics (877) 722-6339.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- CDM
- Quantity affected
- 7536 Bottles
- Distribution
- Worldwide Distribution - US Nationwide in the states of AZ, MA, SC, WA. and the country of Austria.
- Date initiated
- 2018-06-22
- Date posted
- 2018-07-24
- Date terminated
- 2024-01-12
- Location
- Boca Raton, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACON URINALYSIS REAGENT STRIPS (K061559) | Acon Laboratories Co. | 2006-08-11 |