The Recall Desk
ModerateFDA (Devices)·Z-0427-2022·Announced 2022-01-05

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.

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: 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.
Category
Medical Device — Diagnostic Equipment
Hazard
  • substrate-error
  • test-failure

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.

Related recalls

Same category