FDA Medical Device Recalls (openFDA)
Luminex Corporation: Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
- Recall number
- Z-2008-2021
- Recalling firm
- Luminex Corporation
- Product
- Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
- Status
- Open, Classified
- Initiated
- 2020-10-30
- Posted
- not on file
- Terminated
- not on file
- Reason
- Potential for a false-negative result.
- Root 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
- 17,110
- 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.
- Lot, serial or model codes
- 030320021B, 031220021A, 032720021B, 040820021A, 041020021A, 041720021A, 042220021A, 042920021A, 050520021A, 051220021A, 051920021A, 053020021A, 060520021A, 061220021A, 061720021A, 070120021A, 072420021A, 081820021B, and 082620021A
- 510(k) numbers
- ["K132843"]
- PMA numbers
- not on file
- Product code
- OCC
- Firm FEI
- 3006028115
- Firm city
- Northbrook
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28