Recall Z-2094-2017 ยท OOI Real Time Nucleic Acid Amplification System
Luminex Corporation
ARIES System and ARIES M1 System
| Date | Apr 19, 2017 |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |