CLASS II ONGOING Device recall · Reported 1 Nov 2023 · FDA Enforcement Report
HealthyWiser UriTest" UTI Test Strips recalled by Universal Meditech
Universal Meditech is recalling HealthyWiser UriTest" UTI Test Strips, distributed in 8 states. The recall was initiated on 22 May 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0045-2024
- FDA event ID
- 92659
- Recalling firm
- Universal Meditech, Reedley, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 May 2023
- FDA classified
- 23 Oct 2023
- Reported
- 1 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Temperature Abuse
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 22 May 2023 | Recall initiated by company | |
| 23 Oct 2023 | Classified by FDA | +154 days |
| 1 Nov 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
HealthyWiser UriTest" UTI Test Strips REF 900-UTI
Where it was distributed
U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan
CaliforniaFloridaIllinoisLouisianaNew JerseyNew YorkTexasWyoming
Questions about this recall
Why was it 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.
Which lots are affected?
Model Number: 900-UTI UDI-DI Code: None Lot Numbers: URS-1-2102-03 URS-1-2106-01 URS-1-2202-01-Q URS-1-2204-01 URS-1-2207-01 URS-1-2209-01
Where was it sold?
U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
26 other products · FDA event 92659This product is part of a recall event; the main page for the event is DiagnosUS Sars-CoV-2 Antibody (IgG/IgM) Test recalled.
More recalls from Universal Meditech
All 28| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | PrestiBio Pregnancy Strips recalled by Universal Meditech | Universal Meditech | Temperature Abuse | 8 states |
| Device | CLASS II | Am I Pregnant? One Step HCG Pregnancy Test recalled | Universal Meditech | Temperature Abuse | 8 states |
| Device | CLASS II | PrestiBio Breast Milk Alcohol Test Strip recalled by Universal Meditech | Universal Meditech | Temperature Abuse | 8 states |
| Device | CLASS II | To Life hCG Pregnancy Urine Test Strips Format recalled | Universal Meditech | Temperature Abuse | 8 states |
| Device | CLASS II | HealthyWiser KetoFast" Ketone Test Strips recalled by Universal Meditech | Universal Meditech | Temperature Abuse | 8 states |
Other Insulin Pumps & Glucose Monitors recalls
All 459| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | CA |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | CA |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | CA |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Device Malfunction | CA |
| Device | CLASS I | Omnipod (Eros) Pod recalled by Insulet | Insulet | Packaging Defects | Nationwide |