Z-0054-2021Class II

VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and...

Name: Z-0054-2021 VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and...
Creator: Luminex Corporation
Published: 2018-12-10
License: https://open.fda.gov/license/

Luminex Corporation / initiated 2018-12-10 / Open, Classified / root cause: design

FDA source

Luminex Corporation began a recall of VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids on 2018-12-10. FDA classified it as Class II and gives the reason as "No results/incorrect results due to failure of the hybridization heater". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0054-2021
Classification: Class II
Status: Open, Classified
Initiated: 2018-12-10
Posted: 2020-10-05
Recalling firm: Luminex Corporation
Product: VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
Product code: OCC Respiratory Virus Panel Nucleic Acid Assay System
Reason for recall: No results/incorrect results due to failure of the hybridization heater.
Root cause tag: design
FDA root cause: Component design/selection
Action: On or about 11/19/2018 there was one complaint from a customer regarding a thermal control failure. In response to the complaint the Field Service Engineer replaced hybridization heater and ran all tests as passed. Subsequently, the customer reported the initial service was ineffective. The VERIGENE SP Processor was then removed from the customer site and returned for analysis. No Customer Notification was communicated for this removal.
Quantity in commerce: 1 system
Distribution: US distribution in MO. No OUS
Product codes and lots: Catalogue Number: 10-0000-07 Serial No. 14230205 UDI Code: 00857573006010

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0054-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0054-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-14	2020-10-05

Product code OCC

K143653Class IIVerigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)Nanosphere, Inc. / cleared 2015-09-04

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)