Luminex Aries M1 System Model: Aries M6V1 Aries Software v1 — Class II medical device recall Z-2292-2019
Terminated recall by Luminex Corporation, reported 2019-08-28, distributed nationwide. An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners could result in sa
| Recall number | Z-2292-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Luminex Corporation, Austin, TX, United States |
| Recall initiated | 2018-06-29 |
| Classified | 2019-08-19 |
| Reported by FDA | 2019-08-28 |
| Terminated | 2021-04-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, GB, IE, NL, SG, TH |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00840487100080, 00840487101537 |
| Model numbers | JDK-2330 |
Product
Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017
Reason for recall
An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners could result in sample/patient mismatch or duplicate results (from other patients specimens) for a patient order.
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-2292-2019. 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.