Prestibio Urinalasys Test Strip 10 Parameters recall
PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10
Why was Prestibio Urinalasys Test Strip 10 Parameters recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: 900-10 UDI-DI Code: None Lot Numbers: All products manufactured after March 2021
- Product
- PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10
- Recalling firm
- Universal Meditech Inc.
- Quantity
- Unknown
- Distribution
- U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan
- Recall date
- November 1, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)