Z-1092-2022Class II

Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system

Name: Z-1092-2022 Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Creator: Luminex Corporation
Published: 2022-04-05
License: https://open.fda.gov/license/

Luminex Corporation / initiated 2022-04-05 / Open, Classified

FDA source

Luminex Corporation began a recall of Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system on 2022-04-05. FDA classified it as Class II and gives the reason as "Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1092-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-05
Posted: 2022-05-13
Recalling firm: Luminex Corporation
Product: Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Product code: OOI Real Time Nucleic Acid Amplification System
Reason for recall: Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
FDA root cause: Under Investigation by firm
Action: On 04/21/22 Luminex issued a "Urgent Medical Device Recall" Notification to affected consignees. On 6/16/22 and 7/14/22 Luminex expanded the recall to include additional serial numbers. Luminex is asking consignees to take the following actions: 1. Continue use of your VERIGENE Processor SP as service has been completed by a Luminex Field Service Engineer and the Processor SP s heaters are now within specification. 2. Perform a retrospective review of results for VERIGENE Gram-Positive Blood Culture (BC-GP) and VERIGENE Gram-Negative Blood Culture (BC-GN) Nucleic Acid Tests from 18 months prior to the most recent service visit. Identify any results that were not consistent with other clinical signs and symptoms. Promptly inform Luminex of any previously unreported incidences of false results. 3. Distribute the notification to any individuals within your organization who need to be made aware. 4. Please reach out to Global Support Services if a copy of the service record is required. 5. Please complete the Acknowledgement & Receipt form and return within 10 business days.
Quantity in commerce: 24 units
Distribution: US:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: None
Product codes and lots: Serial Numbers for 10-0000-07: 17340003 19044007 20133004 18128002 18214004 12061048 18191010 13193254 13051068 21029902 16277059 19233005 11250096 14069051 18255003 *18039010 *20212006 *19317004 *19206009 *18057008 Serial Numbers added 6.23.22 for 10-0000-07R: 18191010 13051068 14069051 *12198198 *12278344 *14322267 *12271338 Serial Numbers added 7.14.22 for 10-0000-07R: 18226007 and 16242043 Serial Numbers added 7.14.22 for 10-0000-07: 17062030, 18235008 and 19192006

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1092-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1092-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-25	2022-05-13

Product code OOI

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)