FDA Device recall Z-2094-2017
ARIES System and ARIES M1 System
- FDA Device
- Class II
- terminated
- Published 2017-05-24
On 2017-05-24 the FDA classified a Class II recall of ARIES System and ARIES M1 System by Luminex, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2094-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-19 |
| Published | 2017-05-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Luminex |
| Distribution | n/a |
Product
ARIES System and ARIES M1 System
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.
Identifiers
| code_info | ARIES System UDI: 00840487101537 and ARIES M1 System UDI: 00840487100080 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2094-2017%22
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