FDAClass IIJanuary 5, 2022

VIDAS TOXO IgG Avidity recall

VIDAS TOXO IgG Avidity (TXGA), REF 30222-01

Why was VIDAS TOXO IgG Avidity recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI 03573026263010, Lot #: 1008861590

Product
VIDAS TOXO IgG Avidity (TXGA), REF 30222-01
Recalling firm
bioMerieux, Inc.
Quantity
One lot
Distribution
US Nationwide distribution.
Recall date
January 5, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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