Recall Z-2009-2021
Luminex Corporation · initiated October 30, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
Codes / lots: 030420023A, 031720023A, 032520023A, 040820023B, 041520023B, 042220023B, 042820023A, 050120023A, 050620023B, 050820023B, 052720023A, 052820023A, 060420023A, 060620023A, 061120023A, 061820023A, 062520023A, 062720023A, 070220023A, 070920023A, 071420023A, 071720023A, 072820023A, 080420023A, and 090920023A
Reason for recall
Potential for a false-negative result.
FDA-determined cause: Device Design
Action taken
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
Details
- Recall number
- Z-2009-2021
- Initiated
- October 30, 2020
- Product code
- OCC – Respiratory Virus Panel Nucleic Acid Assay System
- Quantity
- 24,338
- 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.
- Recalling firm
- Luminex Corporation, Northbrook, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2006-2021 Class II | Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024Potential for a false-negative result. | 10/30/2020Open, Classified |
| Z-2007-2021 Class II | Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018Potential for a false-negative result. | 10/30/2020Open, Classified |
| Z-2008-2021 Class II | Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021Potential for a false-negative result. | 10/30/2020Open, Classified |
| Z-2010-2021 Class II | Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022Potential for a false-negative result. | 10/30/2020Open, Classified |
| Z-2011-2021 Class II | Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number:…Potential for a false-negative result. | 10/30/2020Open, Classified |