Z-1109-2022Class II

VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021

Name: Z-1109-2022 VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
Creator: Luminex Corporation
Published: 2022-02-15
License: https://open.fda.gov/license/

Luminex Corporation / initiated 2022-02-15 / Open, Classified / root cause: packaging

FDA source

Luminex Corporation began a recall of VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021 on 2022-02-15. FDA classified it as Class II and gives the reason as "Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1109-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-02-15
Posted: 2022-05-17
Recalling firm: Luminex Corporation
Product: VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
Product code: PEP Molecular Erythrocyte Typing Test
Reason for recall: Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Luminex sent a product recall notice on 02/15/2022 by email. The notice informed the user of "No Call Internal Control failures" and requested that they contact Luminex Global Support Services at [email protected] to arrange for replacement and confirm the disposal of any kits in inventory.
Quantity in commerce: 984 units
Distribution: US
Product codes and lots: Lot Number 101321021B

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1109-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1109-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-25	2022-05-17

Product code PEP

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)