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U.S. Department of Health and Human Services

Class 2 Device Recall VIDAS Varicella Zoster IgG (VZG)

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 Class 2 Device Recall VIDAS Varicella Zoster IgG (VZG)see related information
Date Initiated by FirmDecember 10, 2019
Create DateFebruary 07, 2020
Recall Status1 Terminated 3 on February 16, 2021
Recall NumberZ-1107-2020
Recall Event ID 84439
510(K)NumberK923122 
Product Classification Enzyme linked immunoabsorbent assay, varicella-zoster - Product Code LFY
ProductVIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
Code Information US Model 30217-01 Lot 1007410330 and 1007393380
FEI Number 3002769706
Recalling Firm/
Manufacturer		 bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information ContactAnne St¿phanie GUIGNOT
919-620-2000
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionUsers are instructed via customer letter to stop using the VIDAS VZG batches 1007410330 and 1007393380 and destroy the remaining products.
Quantity in Commerce1,218 US units total (726 US, 492 OUS)
DistributionDistributed nationwide and 9 units to Biomerieux Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LFY
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