PrestiBio Breast Milk Alcohol Test Strips Recalled for Lack of Marketing Authorization
Universal Meditech Inc. is recalling PrestiBio Breast Milk Alcohol Test Strips because the company distributed them without FDA marketing authorization and cannot verify they were manufactured properly. The firm is ceasing operations and cannot fulfill post-market responsibilities.
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: This is an FDA Class II recall involving unverified manufacturing and lack of quality system documentation. No illnesses, injuries, or hospitalizations have been reported. The hazard is a risk of unknown device performance due to inability to verify manufacturing compliance and modifications, which qualifies as a risk-of-harm product without reported injury per the rubric (score 3—High).
Plain-English summary
Universal Meditech Inc. is recalling all PrestiBio Breast Milk Alcohol Test Strips (Model 910-10, 25-test kits) manufactured after March 2021. The products were distributed in the United States (California, Florida, Illinois, Louisiana, New Jersey, New York, Texas, and Wyoming) and internationally in Taiwan.
Universal Meditech Inc. distributed these devices without FDA marketing authorization. The firm is ceasing operations and cannot fulfill post-market responsibilities for these products. The FDA has been unable to verify that the devices were manufactured in accordance with federal Quality System Regulation requirements. Additionally, the FDA lacks documentation confirming the devices were not modified since original clearance, were maintained under controlled storage conditions, or had adequate post-market surveillance procedures.
If you have purchased this product, contact Universal Meditech Inc. for return instructions. Report any adverse events or complications related to this product to the FDA.
The recalled product
- Product
- PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS
- 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
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