Generic Name: Kit, Urine, Clean Catch Trade Name: Kit: Urinary Clean Catch 20/cs Model/Catalog Number: 76769 Lot Number: 333606 UDI-DI: 20809160118228 Software Version: N/A

An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027.

On 07/09/2026, an "URGENT: MEDICAL DEVICE FIELD CORRECTION" Letter was emailed to customers informing them that, due to an internal error, item 76769, KIT: Urinary Clean Catch, was inadvertently assigned an incorrect expiration date of 2027/03/31. The correct expiration date is 2027/02/28. Product was distributed between 09/24/2025 to 12/17/2025. On 08/03/2026, an updated "URGENT: MEDICAL DEVICE FIELD CORRECTION" letter was emailed to customer to notify them that, The previous notifications, dated July 9, 2026 and July 24, 2026, contained an incorrect lot number. As stated below, the correct lot number is 76769. Customers were instructed to: 1. Identify and quarantine all impacted product. 2. Add warning labels to impacted product with the new expiration date. A labeling template is enclosed for printing labels which can be affixed on all affected product in inventory. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. - Customers (end-users): If you received product from a distributor, contact the distributor or your sales representative with any questions you may have. - Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. 3. Complete the attached Recall Response Form and return by August 21, 2026. For questions - contact Regulator Affairs at 844-425-9273 or email [email protected]