Z-2533-2024Class II

Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test

Name: Z-2533-2024 Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Creator: Luminex Corporation
Published: 2024-06-20
License: https://open.fda.gov/license/

Luminex Corporation / initiated 2024-06-20 / Open, Classified

FDA source

Luminex Corporation began a recall of Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test on 2024-06-20. FDA classified it as Class II and gives the reason as "Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2533-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-20
Posted: 2024-08-08
Recalling firm: Luminex Corporation
Product: Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Product code: PAM Gram-Positive Bacteria And Their Resistance Markers
Reason for recall: Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
FDA root cause: Under Investigation by firm
Action: Diasorin sent a recall notification on 06/20/2024, via email. Consignees were instructed to examine inventory and quarantine any affected units, arrange for replacement and confirm disposal of any of affected units on hand. Customers were asked to perform a retrospective review of results for VERIGENE Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) to look for any false positives, distribute the notification to any relevant personnel, notify consignees if further distributed and complete and return the "Acknowledgement & Receipt Form."
Quantity in commerce: 1,100 kits
Distribution: US Nationwide distribution including in the states of AZ, CA, CO, DE, FL, GA, IA, IL, KY, MD, MI, MN, MO, MS, NE, NV, OH, OK, SC, TN, TX, VA, VT, WA, WV.
Product codes and lots: GTIN Number: 00840487101575; Catalog Number: 20-006-018; Lot Number: 031824018A; Expiration Date: 09/16/2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2533-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2533-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-08

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)