FDA Medical Device Recalls (openFDA)
Luminex Corporation: Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
- Recall number
- Z-0920-2022
- Recalling firm
- Luminex Corporation
- Product
- Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
- Status
- Open, Classified
- Initiated
- 2019-04-22
- Posted
- not on file
- Terminated
- not on file
- Reason
- Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.
- 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
- 4 units
- Distribution
- US: TX, CT, LA
- Lot, serial or model codes
- Model Number 10-0000-07, Serial Numbers: 13042054,16347082,17215010; Model Number 10-0000-07-R, Serial Numbers: 18079010
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NSU
- Firm FEI
- 3006028115
- Firm city
- Northbrook
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28