FDA Medical Device Recalls (openFDA)
Luminex Corporation: VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
- Recall number
- Z-0054-2021
- Recalling firm
- Luminex Corporation
- Product
- VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
- Status
- Open, Classified
- Initiated
- 2018-12-10
- Posted
- not on file
- Terminated
- not on file
- Reason
- No results/incorrect results due to failure of the hybridization heater.
- Root cause
- Component design/selection
- Action
- On or about 11/19/2018 there was one complaint from a customer regarding a thermal control failure. In response to the complaint the Field Service Engineer replaced hybridization heater and ran all tests as passed. Subsequently, the customer reported the initial service was ineffective. The VERIGENE SP Processor was then removed from the customer site and returned for analysis. No Customer Notification was communicated for this removal.
- Quantity
- 1 system
- Distribution
- US distribution in MO. No OUS
- Lot, serial or model codes
- Catalogue Number: 10-0000-07 Serial No. 14230205 UDI Code: 00857573006010
- 510(k) numbers
- ["K143653"]
- PMA numbers
- not on file
- Product code
- OCC
- Firm FEI
- 3002524000
- Firm city
- Austin
- Firm state
- TX
- 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