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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 VIDAS see related information
Date Initiated by Firm February 09, 2022
Date Posted March 14, 2022
Recall Status1 Open3, Classified
Recall Number Z-0742-2022
Recall Event ID 89568
510(K)Number K933549  
Product Classification Antibody igm,if, cytomegalovirus virus - Product Code LKQ
Product VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
Code Information Lot numbers 1008873260, exp. 01JUN2022.
Recalling Firm/
Manufacturer		 bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information Contact Clinical 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
Action The 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 Commerce 480 kits
Distribution Distribution 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 Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LKQ and Original Applicant = BIOMERIEUX VITEK, INC.
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