Z-2011-2021Class II

Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026

Name: Z-2011-2021 Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026
Creator: Luminex Corporation
Published: 2020-10-30
License: https://open.fda.gov/license/

Luminex Corporation / initiated 2020-10-30 / Open, Classified / root cause: design

FDA source

Luminex Corporation began a recall of Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026 on 2020-10-30. FDA classified it as Class II and gives the reason as "Potential for a false-negative result". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2011-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-10-30
Posted: 2021-07-02
Recalling firm: Luminex Corporation
Product: Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026
Product code: OCC Respiratory Virus Panel Nucleic Acid Assay System
Reason for recall: Potential for a false-negative result.
Root cause tag: design
FDA 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) [email protected]
Quantity in commerce: 165
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.
Product codes and lots: 050620026A and 072120026B,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2011-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2006-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-14	2021-07-02
Z-2007-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-14	2021-07-02
Z-2008-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-14	2021-07-02
Z-2009-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-14	2021-07-02
Z-2010-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-14	2021-07-02
Z-2011-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-14	2021-07-02

Product code OCC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)