Diagnostic Test Strips Recalled Due to Manufacturing Documentation Failures and Company Closure
Multiple diagnostic test products recalled due to company closure and inability to provide manufacturing and quality control documentation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: These are diagnostic test devices with unknown performance characteristics due to lack of manufacturing and quality system documentation. While classified as FDA Class II recall with no reported illnesses or injuries, the devices present a risk of harm through potentially incorrect test results, which could impact patient health decisions.
Plain-English summary
Universal Meditech Inc. is recalling multiple diagnostic test products that were distributed without proper marketing authorization. The products being recalled include PrestiBio Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast Ketone Test Strips, and PrestiBio Ketone Test Strips.
The recall was initiated because Universal Meditech Inc. is going out of business and cannot fulfill post-market responsibilities for these products. More significantly, the company is unable to provide documentation that these devices were manufactured in conformance with FDA's Quality System Regulation. Critical missing documentation includes Device History Files, records of manufacturing controls, controlled storage temperature and humidity conditions, and post-market surveillance data such as consumer complaints and adverse event reports.
Because of these documentation gaps, the actual performance characteristics and safety of these devices cannot be verified. While the company claims to hold 510(k) approvals for some devices, the FDA has been unable to verify these claims or confirm that the distributed devices were not modified in ways that could affect their safety or effectiveness.
Consumers and healthcare providers who have obtained these test products should discontinue use immediately. If you have previously used these devices and have concerns about your test results, consult with a healthcare provider.
The recalled product
- Product
- One Step Ovulation Test REF 200-01
- Manufacturer
- Universal Meditech Inc.
- Affected units
- 100,000
Distribution
Part of a larger recall action
This product is one of 27 recalled by Universal Meditech Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 27 products in this recall →Related recalls
Same manufacturer · Universal Meditech Inc.
See all →- ModerateMultiple Diagnostic Test Strips Recalled for Unverified Quality Standards
FDA (Devices) · 2023-11-01
- HighKetone Test Strips Recalled for Lack of FDA Marketing Authorization
FDA (Devices) · 2023-11-01
- ModeratePregnancy test strips recalled for lack of FDA authorization and quality documentation
FDA (Devices) · 2023-11-01
- HighSARS-CoV-2 Antibody Test Recalled Due to Manufacturing Compliance Issues
FDA (Devices) · 2023-11-01
- HighOMTMO Ovulation Test Strips Recalled for Unverified Manufacturing Quality
FDA (Devices) · 2023-11-01
Same hazard · unverified performance
See all →- HighDiagnosUS Ovulation Predictor test recalled due to unverified manufacturing documentation
FDA (Devices) · 2023-11-01
- HighPregnancy Test Cassettes Recalled for Unverified Performance and Authorization
FDA (Devices) · 2023-11-01
- HighDiagnostic test strips recalled for manufacturing non-compliance and unverified performance
FDA (Devices) · 2023-11-01
- HighFDA Recalls Ovulation Test Strips for Unverified Manufacturing and Documentation
FDA (Devices) · 2023-11-01
- HighPrestiBio Urinalysis Test Strips Recalled for Unverified Manufacturing
FDA (Devices) · 2023-11-01
Similar recalls
- ModerateOne Step UTI in vitro diagnostic test recalled for missing FDA approval
FDA (Devices) · 2026-05-13
- ModerateLumiQuick Methadone Test Strips Recalled for Unapproved Distribution
FDA (Devices) · 2014-04-16
- ModerateLumiQuick Methylphenidate Test Strips Recalled for Unapproved Distribution
FDA (Devices) · 2014-04-16
- ModerateLumiQuick MDMA/Ecstasy Strip Recalled for Unauthorized Distribution
FDA (Devices) · 2014-04-16
- HighSwab Drug Products Recalled Due to Manufacturing Validation Uncertainty
FDA (Devices) · 2022-06-08
- ModerateLumiQuick Fecal Occult Blood Test Strips Recalled for Regulatory Violations
FDA (Devices) · 2014-04-16