FDA Medical Device Recalls (openFDA)
Luminex Corporation: VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
- Recall number
- Z-1109-2022
- Recalling firm
- Luminex Corporation
- Product
- VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
- Status
- Open, Classified
- Initiated
- 2022-02-15
- Posted
- not on file
- Terminated
- not on file
- Reason
- Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.
- Root cause
- Under Investigation by firm
- Action
- Luminex sent a product recall notice on 02/15/2022 by email. The notice informed the user of "No Call Internal Control failures" and requested that they contact Luminex Global Support Services at support@luminexcorp.com to arrange for replacement and confirm the disposal of any kits in inventory.
- Quantity
- 984 units
- Distribution
- US
- Lot, serial or model codes
- Lot Number 101321021B
- 510(k) numbers
- ["K132843"]
- PMA numbers
- not on file
- Product code
- PEP
- 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