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U.S. Department of Health and Human Services

Class 2 Device Recall VERIGENE Nucleic Acid Test KitBCGN Extraction Tray

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  Class 2 Device Recall VERIGENE Nucleic Acid Test KitBCGN Extraction Tray see related information
Date Initiated by Firm February 15, 2022
Create Date May 17, 2022
Recall Status1 Open3, Classified
Recall Number Z-1109-2022
Recall Event ID 90129
510(K)Number K132843  
Product Classification Molecular erythrocyte typing test - Product Code PEP
Product VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
Code Information Lot Number 101321021B
Recalling Firm/
Manufacturer		 Luminex Corporation
4088 Commercial Ave
Northbrook IL 60062-1829
For Additional Information Contact Angelo Rago
512-249-3030 Ext. 9029
Manufacturer Reason
for Recall		 Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.
FDA Determined
Cause 2		 Under Investigation by firm
Action Luminex sent a product recall notice on 02/15/2022 by email. The notice informed the user of "No Call Internal Control failures" and requested that they contact Luminex Global Support Services at support@luminexcorp.com to arrange for replacement and confirm the disposal of any kits in inventory.
Quantity in Commerce 984 units
Distribution US
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 = PEP and Original Applicant = NANOSPHERE, INC
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