Z-1903-2025Class II

VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the...

Name: Z-1903-2025 VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the...
Creator: Luminex Corporation
Published: 2025-04-16
License: https://open.fda.gov/license/

Luminex Corporation / initiated 2025-04-16 / Completed

FDA source

Luminex Corporation began a recall of VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test on 2025-04-16. FDA classified it as Class II and gives the reason as "It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-1903-2025
Classification: Class II
Status: Completed
Initiated: 2025-04-16
Posted: 2025-06-03
Recalling firm: Luminex Corporation
Product: VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test
Product code: PEN Gram-Negative Bacteria And Associated Resistance Markers
Reason for recall: It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.
FDA root cause: Under Investigation by firm
Action: Diasorin issued an Urgent Field Safety Notice to its consignees on 04/16/2025 via email. The notice explained the issue, potential risk to health, and requested the following: "Actions to be taken by the Customer/User 1. Please examine your inventory for the affected products, cease all use, and isolate or quarantine them pending disposal. 2. If you currently have any of the identified affected barcode serial numbers from VERIGENE BC-GN Nucleic Acid Test Cartridge, Lot 022525021A, please contact Technical Support at [email protected] to arrange for replacement and confirm the disposal of any remaining tests in your inventory per the package insert disposal guidelines. 3. Perform a retrospective review of results for VERIGENE Gram-Negative Blood Culture Nucleic Acid Test (BC-GN). If you have encountered a false negative result with a patient sample tested with the potentially impacted portion of Lot 022525021A, please contact Technical Support at [email protected]. 5. If you are a distributor, provide a copy of this letter to any customers or organizations who may have received VERIGENE BC-GN Nucleic Acid Test Cartridge, Lot 022525021A. 6. Please complete the Acknowledgement & Receipt Form and return it to Technical Support. 7. For those with complaints, questions, or concerns please contact Technical Support at 1-877-785-2323 (U.S) or +1-512-381-4397 (Outside U.S.)."
Quantity in commerce: 89 units
Distribution: US Nationwide distribution in the states of AL, CA, MN, TX, AZ, NJ, WA, SC, VA, GA, VT, CT, MD.
Product codes and lots: UDI/DI 00840487101599, Lot Number 022525021A, exp. 08/26/2025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1903-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1903-2025	Class II	Completed	Voluntary: Firm initiated	2025-06-11	2025-06-03

Product code PEN

K132843Class IIVerigene Gram Negative Blood Culture Nucleic Acid Test (Bc-Gn)Nanosphere, Inc. / cleared 2014-01-08

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)