VIDAS Varicella Zoster IgG recall
VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
Why was VIDAS Varicella Zoster IgG recalled?
Two batches of VIDAS Varicella-Zoster IgG (VZG ref 30217) may yield an invalid calibration which may delay the patient's sample result or a valid calibration may lead to a false positive patient result.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
US Model 30217-01 Lot 1007410330 and 1007393380
- Product
- VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
- Recalling firm
- bioMerieux, Inc.
- Quantity
- 1,218 US units total (726 US, 492 OUS)
- Distribution
- Distributed nationwide and 9 units to Biomerieux Canada.
- Recall date
- February 19, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)