Medical Device FSH Test Substrate Error Causes Failed Tests and Delayed Results
bioMerieux is recalling VIDAS FSH test kits due to substrate errors that prevent the test from running, requiring repeated testing and delaying results.
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 device recall with a functional defect (substrate error). No illnesses or injuries reported. The hazard is operational—delayed test results—rather than direct patient safety harm.
Plain-English summary
bioMerieux, Inc. is recalling one lot (No. 1008781470) of VIDAS FSH, REF 30407-01, a follicle-stimulating hormone immunoassay test, due to a substrate error. The error prevents the test from being run as intended.
When the substrate error occurs, users cannot complete the test and must run another test to obtain results. This leads to delayed test results. bioMerieux has received an increasing number of complaints related to this substrate error.
The affected product (UDI 03573026156947) was distributed nationwide throughout the United States.
The recalled product
- Product
- VIDAS FSH, REF 30407-01
- Manufacturer
- bioMerieux, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI 03573026156947
- Lot #: 1008781470
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 recalled by bioMerieux, 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.
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