Multiple Diagnostic Test Strips Recalled for Unverified Quality Standards
Universal Meditech Inc. is recalling multiple diagnostic test strips (breastmilk alcohol, SARS-CoV-2 antibody, and ketone tests) distributed in the U.S. and Taiwan because the company is closing and cannot provide documentation of manufacturing compliance or post-market surveillance records.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The recall is precautionary, based on the company's inability to verify manufacturing compliance with Quality System regulations and failure to provide post-market surveillance documentation, rather than an identified product defect.
Plain-English summary
Universal Meditech Inc. is recalling multiple diagnostic test products distributed in the United States (California, Florida, Illinois, Louisiana, New Jersey, New York, Texas, and Wyoming) and Taiwan. The recalled products include PrestiBio Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast Ketone Test Strips, and PrestiBio Ketone Test Strips. All products manufactured after March 2021 are included in this recall.
Universal Meditech distributed these devices without marketing authorization. The company is closing operations and will be unable to continue fulfilling post-market responsibilities. The FDA has been unable to verify that the company holds the 510(k) authorizations it claims to have for these devices.
The company cannot provide documentation that the devices were manufactured in conformance with FDA Quality System regulations. Missing documentation includes Device History Records, records of controlled storage conditions, and post-market surveillance documentation such as adverse event reports and consumer complaints. Because of these documentation gaps, the actual performance and safety characteristics of the distributed devices cannot be verified.
The recalled product
- Product
- PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF Test Strips
- Manufacturer
- Universal Meditech Inc.
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 →- 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
- HighDiagnostic Test Strips Recalled Due to Manufacturing Documentation Failures and Company Closure
FDA (Devices) · 2023-11-01
- HighOMTMO Ovulation Test Strips Recalled for Unverified Manufacturing Quality
FDA (Devices) · 2023-11-01
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