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U.S. Department of Health and Human Services

Class 2 Device Recall xTAG Gastrointestinal Pathogen Panel (GPP) Kit

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  Class 2 Device Recall xTAG Gastrointestinal Pathogen Panel (GPP) Kit see related information
Date Initiated by Firm February 22, 2019
Create Date June 10, 2019
Recall Status1 Open3, Classified
Recall Number Z-1767-2019
Recall Event ID 82745
510(K)Number K140377  
Product Classification Gastrointestinal pathogen panel multiplex nucleic acid-based assay system - Product Code PCH
Product xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool (GPP) Kit, IVD, REF I032C0316.
Code Information Lot numbers IK032C-00061, exp. 11/30/2018; IK032C-00063, exp. 11/30/2018; IK032C-00064, exp. 12/31/2018; IK032C-00066, exp. 12/31/2018; IK032C-00067, exp. 11/30/2018; IK032C-00068, exp. 4/30/2019; IK032C-00069, exp. 7/31/2019; and IK032C-00071, exp. 12/31/2018; UDI 00840487100493.
Recalling Firm/
Manufacturer		 Luminex Molecular Diagnostics
439 University Ave Suite 900
Toronto Canada
Manufacturer Reason
for Recall		 Reports have been received of lower MS2 MFI values when using the panel.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The recalling firm issued letters via email dated 2/22/2019.
Quantity in Commerce 965 kits
Distribution Distribution from the firm's Austin, Texas, location was made to AL, AR, AZ, CA, FL, GA, IL, IN, MO, NC, ND, NJ, NY, OK, TN, TX, VA, and WI. There was military distribution but no government 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 = PCH and Original Applicant = LUMINEX MOLECULAR DIAGNOSTICS, INC.
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