CLASS II ONGOING Device recall · Reported 1 Nov 2023 · FDA Enforcement Report

PrestiBio Ovulation and Pregnancy Strips recalled by Universal Meditech

Universal Meditech is recalling PrestiBio Ovulation and Pregnancy 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

Lot, batch or date codesModel Number: 100-4 and 200-4 UDI-DI Code: None Lot Numbers: All products manufactured after March 2021

Quantity recalledUnknown

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-0053-2024
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

PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF Test Strips

Where it was distributed

U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan

California Florida Illinois Louisiana New Jersey New York Texas Wyoming

Questions about this recall

Is PrestiBio Ovulation and Pregnancy Strips recalled?

Yes. Universal Meditech recalled PrestiBio Ovulation and Pregnancy Strips on 22 May 2023. The recall is Class II and its status is Ongoing. Recall number Z-0053-2024.

Why was it recalled?

Which lots are affected?

Model Number: 100-4 and 200-4 UDI-DI Code: None Lot Numbers: All products manufactured after March 2021

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Universal Meditech

All 28

Reported	Class	Recall	Company	Reason	Where
1 Nov 2023Device	CLASS II	PrestiBio Pregnancy Strips recalled by Universal Meditech	Universal Meditech	Temperature Abuse	8 states
1 Nov 2023Device	CLASS II	Am I Pregnant? One Step HCG Pregnancy Test recalled	Universal Meditech	Temperature Abuse	8 states
1 Nov 2023Device	CLASS II	PrestiBio Breast Milk Alcohol Test Strip recalled by Universal Meditech	Universal Meditech	Temperature Abuse	8 states
1 Nov 2023Device	CLASS II	To Life hCG Pregnancy Urine Test Strips Format recalled	Universal Meditech	Temperature Abuse	8 states
1 Nov 2023Device	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
26 Aug 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Other	Nationwide
26 Aug 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Other	Nationwide
26 Aug 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Other	Nationwide
15 Jul 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Lead & Heavy Metals	Nationwide
8 Jul 2026Device	CLASS I	Omnipod (Eros) Pod recalled by Insulet	Insulet	Lead & Heavy Metals	Nationwide