The Recall Desk
HighFDA (Devices)·Z-0437-2022·Announced 2022-01-05

VIDAS Lyme diagnostic test device recalled due to substrate error

bioMerieux recalled VIDAS Lyme IgG II test devices (two lots) due to a substrate error that prevents tests from running. Users must retest patients, potentially delaying Lyme disease diagnosis.

What this means for you

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: This is a Class II recall of a diagnostic device. Although no illnesses or injuries have been reported, the substrate error prevents test execution and creates a risk of harm through potential diagnostic delays for a serious disease.

Plain-English summary

bioMerieux, Inc. is recalling two lots of VIDAS Lyme IgG II diagnostic test devices (REF 417401). The affected lots are 1008714880 and 1008824220. The product was distributed nationwide in the United States.

A substrate error prevents the test from running properly. When the error occurs, users cannot obtain test results and must run the test again. This can delay diagnosis of Lyme disease.

Healthcare facilities and laboratories using the affected lots should discontinue use and contact bioMerieux for replacement units or guidance. Patients with pending test results should consult their healthcare provider about the delay.

The recalled product

Product
VIDAS Lyme IgG II (LYM), REF 417401
Manufacturer
bioMerieux, Inc.
Category
Medical Device — Diagnostic Test Equipment
Hazard
  • test-malfunction
  • diagnostic-delay

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 (3)

  • UDI 03573026458270
  • Lot #: 1008714880
  • 1008824220

Distribution

Distributed nationwide across the United States.

Related recalls

Same category