| Class 2 Device Recall VIDAS |  |
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
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Product | VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx. |
Code Information |
Lot numbers 1008873260, exp. 01JUN2022.
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Recalling Firm/ Manufacturer |
bioMerieux, Inc. 100 Rodolphe St Durham NC 27712-9402
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = LKQ
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