OMTMO Ovulation Test Strips Recalled for Unverified Manufacturing Quality
Universal Meditech Inc. is recalling 40,000 OMTMO ovulation test strips because the manufacturer is closing operations and cannot provide required manufacturing and quality 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: FDA Class II recall of medical test strips distributed without marketing authorization; devices may have unknown performance characteristics due to lacking required manufacturing and quality documentation, representing a potential risk of incorrect test results; no illnesses or injuries reported.
Plain-English summary
Universal Meditech Inc. is recalling 40,000 OMTMO One Step Ovulation (LH) Test Strips, Model 200-07, distributed in California, Florida, Illinois, Louisiana, New Jersey, New York, Texas, Wyoming, and Taiwan. The recall includes all test strips manufactured after March 2021, specifically including lot number LH-S-2108-01.
Universal Meditech Inc. initiated the recall because the company is ceasing operations and cannot continue to fulfill post-market responsibilities. Additionally, the FDA found that the manufacturer distributed these test strips without obtaining the required marketing authorization. Although the company claims to hold FDA 510(k) clearances, the FDA has been unable to verify this claim. The company states it purchased the product intellectual property in 2015 from a previous 510(k) holder but has not provided supporting documentation.
The FDA's inspection revealed that Universal Meditech Inc. cannot provide documentation showing the test strips were manufactured in compliance with FDA Quality System Regulations. The company lacks Device History Files, records of controlled storage temperature and humidity, and post-market surveillance documentation including customer complaints and adverse events. Due to these documentation deficiencies, the devices may have unknown performance characteristics and their actual performance cannot be verified.
The recalled product
- Product
- OMTMO One Step Ovulation (LH) Test Strips REF 200-07
- Manufacturer
- Universal Meditech Inc.
- Affected units
- 40,000
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
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