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U.S. Department of Health and Human Services

Class 2 Device Recall Verigene Processor SP

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  Class 2 Device Recall Verigene Processor SP see related information
Date Initiated by Firm December 10, 2018
Create Date October 05, 2020
Recall Status1 Open3, Classified
Recall Number Z-0054-2021
Recall Event ID 86358
510(K)Number K143653  
Product Classification Respiratory virus panel nucleic acid assay system - Product Code OCC
Product VERIGENE Processor SP
Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
Code Information Catalogue Number: 10-0000-07 Serial No. 14230205 UDI Code: 00857573006010
Recalling Firm/
Manufacturer		 Luminex Corporation
12212 Technology Blvd
Austin TX 78727-6101
For Additional Information Contact Wendy Ricker
608-203-8936
Manufacturer Reason
for Recall		 No results/incorrect results due to failure of the hybridization heater.
FDA Determined
Cause 2		 Component design/selection
Action On or about 11/19/2018 there was one complaint from a customer regarding a thermal control failure. In response to the complaint the Field Service Engineer replaced hybridization heater and ran all tests as passed. Subsequently, the customer reported the initial service was ineffective. The VERIGENE SP Processor was then removed from the customer site and returned for analysis. No Customer Notification was communicated for this removal.
Quantity in Commerce 1 system
Distribution US distribution in MO. No OUS
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 = OCC and Original Applicant = NANOSPHERE, INC
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