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U.S. Department of Health and Human Services

Class 2 Device Recall Verigene

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  Class 2 Device Recall Verigene see related information
Date Initiated by Firm August 03, 2021
Create Date September 10, 2021
Recall Status1 Open3, Classified
Recall Number Z-2451-2021
Recall Event ID 88423
510(K)Number K140083  
Product Classification Gastrointestinal pathogen panel multiplex nucleic acid-based assay system - Product Code PCH
Product Verigene EP Amplification Reagent Kit Test
Code Information Model: Verigene Enteric Pathogens (EP) Stool PREP KIT; Catalog Number: 30-002-023; Lots: 111620023A 010421023A, 010621023D, 010721023E, 011121023A, 011221023D, 011821023A, 011921023D, 012521023A, 012821023D, 020921023D, 021021023E, 021721023D 022221023A, 030121023A, 030221023D, 030221023E, 030221023F, 030821023A, 030921023D, 031021023E, 031621023D, 031721023D, 032221023A, 032421023E, 032521023E, 033021023E, 040521023A, 041421023F, 041521023E, 042121023D, 042621023A, 050521023H, 050621023C, 051221023E, 051221023F, 111620023A, 111620023B, 111820023D, 111820023E, 112320023A, 112320023B, 120120023D, 120120023E, 120220023D, 120220023E, 120720023A, 120720023B, 120720023C, 120720023D, 120920023D, 120920023E, 120920023F, 121420023B, 121420023C, 121520023D, 121520023E, 121620023D, 121620023E, 122120023A, 122120023B,, 122220023D, 122220023E, 122820023A, 122820023B, 122920023D, 122920023E, 122920023F
Recalling Firm/
Manufacturer		 Luminex Corporation
4088 Commercial Ave
Northbrook IL 60062-1829
For Additional Information Contact
847-400-9115
Manufacturer Reason
for Recall		 There is potential for false positive results.
FDA Determined
Cause 2		 Process control
Action A customer letter was issued to notify consignees of the recall dated 08/03/2021. Customers are advised to notify Luminex if they are impacted by the recall and Luminex will facilitate replacement of the product. Customers are asked to destroy impacted product and document actions on a return response form.
Quantity in Commerce 4579 kits
Distribution Worldwide distribution - US Nationwide distribution and the countries of Austria, France, Greece, Japan, and Turkey.
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 = PCH and Original Applicant = NANOSPHERE, INC
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