Luminex Corporation Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Brand
Luminex Corporation
Lot Codes / Batch Numbers
18235008 and 19192006
Products Sold
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
Luminex Corporation is recalling Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system due to Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CO, FL, GA, IL, IN, KY, ME, MI, NE, OH, PA, TX, VT, WA
Page updated: Jan 10, 2026