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U.S. Department of Health and Human Services

Class 2 Device Recall VIDAS

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 Class 2 Device Recall VIDASsee related information
Date Initiated by FirmFebruary 09, 2022
Date PostedMarch 14, 2022
Recall Status1 Terminated 3 on April 01, 2026
Recall NumberZ-0742-2022
Recall Event ID 89568
510(K)NumberK933549 
Product Classification Antibody igm,if, cytomegalovirus virus - Product Code LKQ
ProductVIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
Code Information Lot numbers 1008873260, exp. 01JUN2022.
FEI Number 3002769706
Recalling Firm/
Manufacturer		 bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information ContactClinical Customer Support
800-682-2666
Manufacturer Reason
for Recall		Invalid calibrations (out of range high) while using the product.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe recalling firm issued letters dated 2/9/2022 via Fed Ex Express Priority Overnight delivery service to their U.S. consignees. The letter described the issue, the impact to the user, and the required actions. Those actions included instructing the consignee to stop using and destroy any stock of the recalled lot and to complete the Acknowledgement Form and return it via email or FAX. The quantity discarded was to be completed on the Acknowledgement Form.
Quantity in Commerce480 kits
DistributionDistribution was made to CA, FL, GA, IL, IN, LA, MA, MD, ME, MO, NJ, NY, OH, PA, TX, VA, WI, and WV. There was government distribution but no military or foreign distribution.
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 = LKQ
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