Z-0920-2022Class II

Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R

Name: Z-0920-2022 Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
Creator: Luminex Corporation
Published: 2019-04-22
License: https://open.fda.gov/license/

Luminex Corporation / initiated 2019-04-22 / Open, Classified

FDA source

Luminex Corporation began a recall of Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R on 2019-04-22. FDA classified it as Class II and gives the reason as "Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0920-2022
Classification: Class II
Status: Open, Classified
Initiated: 2019-04-22
Posted: 2022-04-13
Recalling firm: Luminex Corporation
Product: Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
Product code: NSU Instrumentation For Clinical Multiplex Test Systems
Reason for recall: Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.
FDA root cause: Under Investigation by firm
Action: The firm sent technicians to sites beginning on 13 March 2019 to test the devices and the devices were subsequently returned. The firm send a notice regarding the recall on 03/10/2022 by email. The notices documented the actions of the firm with respect to the devices.
Quantity in commerce: 4 units
Distribution: US: TX, CT, LA
Product codes and lots: Model Number 10-0000-07, Serial Numbers: 13042054,16347082,17215010; Model Number 10-0000-07-R, Serial Numbers: 18079010

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0920-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0920-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-20	2022-04-13

Product code NSU

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)