Recall record at a glance
| Official record | Z-0063-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Universal Meditech Inc. |
| Report date | Nov 1, 2023 |
| Recall initiation date | May 22, 2023 |
| Quantity | 5,025 tests |
| Location | Reedley, CA, United States |
Official product description
DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12
Why the product was 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.
Distribution information
U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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