Diagnostic substrate error in medical testing device causes test failures
bioMerieux is recalling 1,579 VIDAS DEX@ diagnostic devices due to substrate errors that prevent test execution, requiring users to rerun tests and potentially 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: This is an FDA Class II device recall with a functional defect (substrate error) that prevents test execution. No illnesses, injuries, or hospitalizations are reported. The impact is operational—requiring users to rerun tests and potentially delaying results—rather than a direct safety hazard.
Plain-English summary
bioMerieux, Inc. is recalling 1,579 VIDAS DEX@ (Dimer Exclusion II) diagnostic devices with nationwide U.S. distribution. The devices are recalled due to a substrate error that prevents the test from being run.
When this error occurs, the user must run another test, which can lead to delayed test results. bioMerieux has been receiving an increasing number of complaints related to this substrate error.
The recalled lot numbers are 1008696660, 1008761020, 1008864290, and 1008891690. The device UDI is 03573026387006, REF 30455-01.
The recalled product
- Product
- VIDAS DEX@, Dimer Exclusion II, REF 30455-01
- Manufacturer
- bioMerieux, Inc.
- Affected units
- 1,579
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 (5)
- UDI 03573026387006
- Lot #s: 1008696660
- 1008761020
- 1008864290
- 1008891690
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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