Recall Z-0048-2024 ยท JHI Visual, Pregnancy Hcg, Prescription Use
Universal Meditech Inc.
DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13
| Date | Oct 23, 2023 (initiated May 22, 2023) |
| Status | Open, Classified |
| Reason | 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 info |
| Root 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 notificati |
| Quantity | 4,103 cassettes (25 cassettes/box) |
| Distribution | U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050741 | IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT Ind Diagnostic, Inc., May 16, 2005 |