Class 2 Device Recall Verigene BCGP Test Kit

• Date Initiated by Firm: October 30, 2020
• Create Date: July 02, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2007-2021
• Recall Event ID: 88137
• 510(K)Number: K122514
• Product Classification: Respiratory virus panel nucleic acid assay system - Product Code OCC
• Product: Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018
• Code Information: 030620018A, 031420018A, 032020018A, 040120018A, 041020018B, 041720018B, 042420018A, 043020018A, 050220018A, 050720018A, 050920018A, 051320018A, 051420018A, 051520018A, 052020018A,052120018A, 052920018A, 060220018A, 060920018A, 061020018A, 061620018A, 061920018D, 062020018A, 062620018A, 063020018A, 070720018A, 071620018A, 072320018A, 073020018A, 080520018A, 082020018A, 082520018A, 082820018A, and 090120018A
• 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: 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: 36,416
• 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