Luminex Corporation Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R 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, Model Numbers: 10-0000-07 and 10-0000-07-R
Brand
Luminex Corporation
Lot Codes / Batch Numbers
Model Number 10-0000-07, Serial Numbers: 13042054, 16347082, 17215010, Model Number 10-0000-07-R, Serial Numbers: 18079010
Products Sold
Model Number 10-0000-07, Serial Numbers: 13042054,16347082,17215010; Model Number 10-0000-07-R, Serial Numbers: 18079010
Luminex Corporation is recalling Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R due to Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.
Recommended Action
Per FDA guidance
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.
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
CT, LA, TX
Page updated: Jan 10, 2026