The Recall Desk
ModerateFDA (Devices)·Z-0434-2022·Announced 2022-01-05

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.

What this means for you

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.
Category
Medical Device — In Vitro Diagnostic Test
Hazard
  • substrate-defect
  • test-malfunction

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.

Related recalls

Same category