FDA Device recall Z-0052-2024
PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips
- FDA Device
- Class II
- ongoing
- Published 2023-11-01
On 2023-11-01 the FDA classified a Class II recall of PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips by Universal Meditech, citing universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test St….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0052-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-22 |
| Published | 2023-11-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Universal Meditech |
| Distribution | CA, FL, IL, LA, NJ, NY, TX, WY |
Product
PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips
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 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.
Identifiers
| code_info | Model Number: 200-4 UDI-DI Code: None Lot Numbers: All products manufactured after March 2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0052-2024%22
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