Vidas Lyme Igm II recall
VIDAS Lyme IgM II (LYM), REF 416436
Why was Vidas Lyme Igm II 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 03573026447151, Lot #: 1008636750, 1008768920, 1008857410
- Product
- VIDAS Lyme IgM II (LYM), REF 416436
- Recalling firm
- bioMerieux, Inc.
- Quantity
- Three lots
- Distribution
- US Nationwide distribution.
- Recall date
- January 5, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)