Z-0500-2024Class II

Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF...

Name: Z-0500-2024 Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF...
Creator: Luminex Corporation
Published: 2023-11-07
License: https://open.fda.gov/license/

Luminex Corporation / initiated 2023-11-07 / Open, Classified

FDA source

Luminex Corporation began a recall of Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP... on 2023-11-07. FDA classified it as Class II and gives the reason as "Potentially defective utility trays in the reagent kits". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0500-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-07
Posted: 2023-12-06
Recalling firm: Luminex Corporation
Product: Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.
Product code: PAM Gram-Positive Bacteria And Their Resistance Markers
Reason for recall: Potentially defective utility trays in the reagent kits.
FDA root cause: Under Investigation by firm
Action: The recalling firm issued letters dated 11/7/2023 via email on the same date. The letter explained the reason for recall, risk to health, and actions to be taken by the consignee/distributor. The actions included examining their inventory for the affected product, cease all use, and isolate or quarantine the product pending disposal; contact Luminex Global Support Services to arrange for replacement and confirm the disposal of any remaining kits in inventory; perform a retrospective review of results for VERIGENE Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) and if false negative results with a patient sample tested with the affected lot number have been encountered, contact Luminex Global Support; distribute the notification to any individuals within their organization who need to be made aware of the recall; if the consignee is a distributor, they are to provide a copy of this letter to any customers or organizations who may have received the affected lot number; and complete the enclosed Acknowledgement & Receipt Form and return it to Luminex Technical Support.
Quantity in commerce: 222 kits (4,440 trays)
Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GL, IL, IN, MA, MD, MI, MN, MO, MS, NE, NY, OH, OK, OR, TN, TX, UT, VA, WA, and WI. The country of Italy.
Product codes and lots: Lot number 062123018C, Exp. 12/20/2023, UDI (01)00840487101674(17)231220(10)062123018C.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0500-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0500-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-06

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)