Z-0445-2019Class II

VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers)

Name: Z-0445-2019 VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers)
Creator: Luminex Corporation
Published: 2018-09-14
License: https://open.fda.gov/license/

Luminex Corporation / initiated 2018-09-14 / Terminated / root cause: manufacturing process

FDA source

Luminex Corporation began a recall of VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simultaneous detection... on 2018-09-14. FDA classified it as Class II and gives the reason as "Potential to lead to a false negative results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0445-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-14
Posted: 2018-11-10
Terminated: 2021-04-28
Recalling firm: Luminex Corporation
Product: VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria.
Product code: PAM Gram-Positive Bacteria And Their Resistance Markers
Reason for recall: Potential to lead to a false negative results.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On September14, 2018, Luminex sent Urgent Customer Advisory Notifications to their consignees. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Experience Team.
Quantity in commerce: 12,700 trays
Distribution: Worldwide Distribution - US Nationwide in the states of United States - AZ, CA, CO, CT, DC, FL, GA,, IA, ID, IN, KA,, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NV, NJ, NY, OK,,OH, OR, PA, SC, TN, TX, UT, VT, WA, KS, and VA.. France
Product codes and lots: Supplier raw tray lots 195916-070518 and 190943-073118 Utility Tray Lots: 082518018C, 081618018C, 082918018C, 090418018B, 081118018C and 082718018B

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0445-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0445-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-21	2018-11-09

Product code PAM

K122514Class IIVerigene Gram-Positive Blood Culture (Gc-Gp) Nucleic Acid TestNanosphere, Inc. / cleared 2012-09-19

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)