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.
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 3/5 (High).
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
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.
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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