Class 2 Device Recall PrestiBio BREAST MILK ALCOHOL TEST STRIP

• Date Initiated by Firm: May 22, 2023
• Date Posted: October 23, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0051-2024
• Recall Event ID: 92659
• Product Classification: Breast milk-alcohol test system - Product Code ORA
• Product: PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS
• Code Information: Model Number: 910-10 UDI-DI Code: None Lot Numbers: All products manufactured after March 2021
• Recalling Firm/ Manufacturer: Universal Meditech Inc.; 850 I St; Reedley CA 93654-2819
• For Additional Information Contact: Michael M. Lin; 702-871-9888
• Manufacturer Reason for Recall: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.
• FDA Determined Cause: Other
• Action: On 06/07/2023, the firm emailed customers to inform them of the intent of the firm to recall all products we have sold to them in the past two years; in that email, UMI has advised them to immediately stop further distribution of any product that was made by UMI. In the past few weeks, UMI has conducted a thorough investigation of their order information. We will send formal recall letters to them with all the batch information of all products they have ordered since March 2021. On 06/30/2023, the firm sent via US Certified Post, a hard copy letter of it first version of the recall notification. On 09/02/2023, the firm sent an updated "URGENT: MEDICAL DEVICE RECALL" letter via email to inform customers that Universal Meditech Inc. is going out of business hence would not be able to continue fulfilling any post-market responsibilities for these distributed products. Therefore, the firm decided to recall any products that have not yet been sold to end users. Customers are being advised to immediately stop distributing or using any of the abovementioned devices in your remaining stock. If you have already distributed the device to any other distributors or retailors, we kindly ask you to inform them of the product recall by forwarding this letter to them. Please kindly acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending it back to us. For questions, contact Michael M. Lin, Legal Attorney at 702-871-9888 (9AM to 5PM, PST, MON to FRI) or email ml@linlawgroup.com Firm issued a Press Release - posting at www.universal-meditech.com Update Information (09/15/2023): On 09/17/2023, additional "URGENT: MEDICAL DEVICE RECALL" Letter were sent via email and FedEx, to inform customer of additional products added to the Recall and to indicated that products being recalled are for any products that have not been used and instructing customers to notify customers that they have further distributed the products
• Quantity in Commerce: Unknown
• Distribution: U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.