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U.S. Department of Health and Human Services

Class 2 Device Recall Verigene CDF Test Kit

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  Class 2 Device Recall Verigene CDF Test Kit see related information
Date Initiated by Firm October 30, 2020
Create Date July 02, 2021
Recall Status1 Open3, Classified
Recall Number Z-2010-2021
Recall Event ID 88137
510(K)Number K123197  
Product Classification Respiratory virus panel nucleic acid assay system - Product Code OCC
Product Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
Code Information 041520022A, 061920022A, and 081120022A
Recalling Firm/
Manufacturer		 Luminex Corporation
4088 Commercial Ave
Northbrook IL 60062-1829
For Additional Information Contact LUMINEX Global Support Services
877-785-2323
Manufacturer Reason
for Recall		 Potential for a false-negative result.
FDA Determined
Cause 2		 Device Design
Action On October 2020 the firm sent a letter to all their consignees with the following information: Dear Valued Luminex Customer, According to our records, you have ordered and may have used our portfolio of VERIGENE¿ Assays in your laboratory. Through post-market surveillance activities, we have identified an increase in the No Call/False Positivity rate for these products. Our investigation has identified that the likelihood of a No Call/False Positive for the assays below increases when test cartridges are left on the Processor SP for an extended time following completion of assay preparation. We are currently working on a software solution aimed at further optimizing the washing and drying steps in the sample preparation process. This software update should minimize No Call/False Positive rates for these assays. Until this solution is finalized and implemented, we advise you to remove test cartridges from the VERIGENE¿ SP Processor immediately following completion of assay preparation, and then to process these cartridges on the VERIGENE Reader as soon as possible to obtain test results. While this is common practice for many customers already, doing so should minimize the occurrence of No Call/False Positive results for the products listed below. We will contact you with more details on the software solution soon as possible. Please contact Luminex Global Support Services with any questions or concerns. Luminex Global Support Services 1-877-785-2323 (U.S. and Canada) +1-512-381-4397 (Outside U.S. and Canada) support@luminexcorp.com
Quantity in Commerce 1,261
Distribution Worldwide distribution - US Nationwide including in the states of AL, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA and VT. The countries of Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and United Kingdom.
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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