Summary
The FDA issued a Class II for VIDAS Measles IgG (MSG), REF 30219 by bioMerieux, Inc.. Reason: bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore lea.
Details
Source
Device Recall
External ID
Z-0430-2022
Action Date
2022-01-05
Status
Ongoing
Category
device
Product Description
VIDAS Measles IgG (MSG), REF 30219
Lot/Code Info: UDI 03573026064532, Lot #: 1008890110
Quantity Affected: One lot
Reason for Recall
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-22
Company
Durham, NC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 90 device recalls issued in the same week, part of 413 device-related FDA actions this month.
bioMerieux, Inc. has 146 FDA actions in our database, including 122 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (bioMerieux, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does bioMerieux, Inc. have FDA actions?
bioMerieux, Inc. has 146 FDA actions in our database, including 122 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0430-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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