Pregnancy Test Kits Recalled Due to Unverified Manufacturing and Unauthorized Distribution
Universal Meditech Inc. is recalling PrestiBio Rapid Detection Pregnancy Test Midstream kits (manufactured after March 2021) because the company distributed them without FDA authorization and cannot verify manufacturing compliance.
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 a Class II medical device recall with no reported illnesses or injuries. Per the rubric, theoretical hazards without reported injury score at most 3. A pregnancy test with unknown reliability represents a risk-of-harm product because inaccurate results could affect medical decision-making, warranting High severity despite the absence of documented harm.
Plain-English summary
Universal Meditech Inc. is recalling all PrestiBio Rapid Detection Pregnancy Test Midstream kits (Model 100-17, containing 3 tests per package) manufactured after March 2021. The product was distributed in California, Florida, Illinois, Louisiana, New Jersey, New York, Texas, Wyoming, and Taiwan.
The recall was initiated because Universal Meditech Inc. distributed these tests without FDA marketing authorization. The company is ceasing operations and is unable to continue fulfilling post-market responsibilities. Although UMI claims to hold FDA 510(k) clearances for these devices, the FDA has been unable to verify this claim, and the company cannot provide supporting documentation.
The tests may have unknown safety and performance characteristics. UMI cannot provide documentation demonstrating manufacturing compliance with FDA Quality System regulations, including Device History Files, records of controlled storage conditions, and post-market surveillance data such as complaints and adverse events. Without this documentation, the actual safety and effectiveness of the distributed tests cannot be verified.
Consumers who have purchased this product should not rely on it for medical decision-making. Anyone with questions about pregnancy testing should consult a healthcare provider.
The recalled product
- Product
- PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS
- Manufacturer
- Universal Meditech Inc.
- Category
- Medical Device — Diagnostic Test
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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