ARIES System and ARIES M1 System
This recall has been terminated (originally issued April 19, 2017).
- Company
- Luminex Corporation
- Recall Initiated
- April 19, 2017
- Terminated
- October 20, 2017
- Recall Number
- Z-2094-2017
- Quantity
- 15 units
- Firm Location
- Austin, TX
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide Distribution - US Distribution and to the countries of Finland and China.
Lot / Code Info
ARIES System UDI: 00840487101537 and ARIES M1 System UDI: 00840487100080
Root Cause
Nonconforming Material/Component
Action Taken
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.