The Recall Desk
HighFDA (Devices)·Z-0429-2022·Announced 2022-01-05

VIDAS Mumps IgG diagnostic test kit recalled due to substrate error

bioMerieux is recalling one lot of VIDAS Mumps IgG diagnostic tests because a substrate error prevents the tests from running, causing delays.

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 an FDA Class II device recall. While no illnesses or injuries have been reported, the substrate error prevents the diagnostic test from running, creating a risk of delayed diagnosis and patient harm. This meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

bioMerieux, Inc. is recalling one lot of VIDAS Mumps IgG (MPG) diagnostic test kits (REF 30218). The affected lot (UDI 03573026064525, Lot #1008769120) is distributed nationwide in the United States.

The recall is due to a substrate error that prevents the diagnostic test from running properly. This error requires users to repeat the test, resulting in delayed diagnostic results.

The recalled product

Product
VIDAS Mumps IgG (MPG), REF 30218
Manufacturer
bioMerieux, Inc.
Category
Medical Device — Diagnostic Test
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 (2)

  • UDI 03573026064525
  • Lot #: 1008769120

Distribution

Distributed nationwide across the United States.

Related recalls

Same category