FDA Medical Device Recalls (openFDA)
Luminex Corporation: ARIES System and ARIES M1 System
- Recall number
- Z-2094-2017
- Recalling firm
- Luminex Corporation
- Product
- ARIES System and ARIES M1 System
- Status
- Terminated
- Initiated
- 2017-04-19
- Posted
- not on file
- Terminated
- 2017-10-20
- Reason
- The hand-held barcode scanner that is used as an accessory to enter ARIES cassette and specimen identifications on the ARIES Systems populates patient sample IDs with a previously scanned sample ID when entering orders into an ARIES instrument.
- Root cause
- Nonconforming Material/Component
- Action
- A recall notification letter was sent out on April 19, 2017. Prior to the recall letter being sent, the recalling firm sent a Customer Advisory Notification on April 14, 2017. The firm is also adding an accountability form to the customer notifications in order to document the customer responses to ensure that we account for the estimated 15 distributed units. For further questions, please call (877) 785-2323.
- Quantity
- 15 units
- Distribution
- Worldwide Distribution - US Distribution and to the countries of Finland and China.
- Lot, serial or model codes
- ARIES System UDI: 00840487101537 and ARIES M1 System UDI: 00840487100080
- 510(k) numbers
- ["K151917","K160517","K162772"]
- PMA numbers
- not on file
- Product code
- OOI
- 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