The Recall Desk
HighFDA (Devices)·Z-0430-2022·Announced 2022-01-05

VIDAS Measles IgG Test Kit Recalled Due to Substrate Error

bioMerieux is recalling VIDAS Measles IgG test kits due to a substrate error that prevents the test from running, requiring users to repeat testing and potentially delaying results.

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: FDA Class II medical device with a functional defect preventing test execution and potentially delaying diagnostic results. Although no illnesses or injuries have been reported, this is a risk-of-harm product where delayed diagnosis could impact patient care.

Plain-English summary

bioMerieux, Inc. is recalling VIDAS Measles IgG (MSG), REF 30219 test kits due to a substrate error that prevents the test from being run. Affected users must run another test to obtain results, which may delay test availability.

The recall affects one lot distributed nationwide: Lot #1008890110 (UDI 03573026064532). bioMerieux has received an increasing number of complaints regarding the substrate defect.

No illnesses or injuries have been reported. Users with affected product should contact bioMerieux, Inc. for further instructions.

The recalled product

Product
VIDAS Measles IgG (MSG), REF 30219
Manufacturer
bioMerieux, Inc.
Category
Medical Device — Diagnostic Equipment
Hazard
  • substrate-defect
  • 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 (2)

  • UDI 03573026064532
  • Lot #: 1008890110

Distribution

Distributed nationwide across the United States.

Related recalls

Same category