ARIES System and ARIES M1 System — Class II medical device recall Z-2094-2017
Terminated recall by Luminex Corporation, reported 2017-05-24. The hand-held barcode scanner that is used as an accessory to enter ARIES cassette and specimen identification
| Recall number | Z-2094-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Luminex Corporation, Austin, TX, United States |
| Recall initiated | 2017-04-19 |
| Classified | 2017-05-16 |
| Reported by FDA | 2017-05-24 |
| Terminated | 2017-10-20 |
| Countries outside the US | CN, FI |
| Quantity | 15 units |
| UPC / GTIN / UDI-DI | 00840487100080, 00840487101537 |
Product
ARIES System and ARIES M1 System
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2094-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.