Ind One Step Hcg Urine Pregnancy Test (Strip)

• 3 recalls, same reason

  • Ongoing Z-0054-2024 FDA Class II ·initiated 22 May 2023
  • Ongoing Z-0053-2024 FDA Class II ·initiated 22 May 2023 ·on shared 510(k) K110889
  • Ongoing Z-0042-2024 FDA Class II ·initiated 22 May 2023

  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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K110889 ↗

FDA Product Code

LCX

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Ind One Step Occult Blood (Fob) Test

  Class II

  FDA 510(k) K113506 Active Cleared 19 Dec 2012