Drug recall
Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical…
FDA recall event 81420 · Class II · Luminex Corporation
Key facts
| Event ID | 81420 |
|---|---|
| Recall numbers | Z-2292-2019 |
| Recalling firm | Luminex Corporation |
| Product type | Devices |
| Products | 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 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jun 29, 2018 |
| Report date | Aug 28, 2019 |
| Termination date | Apr 28, 2021 |
| City | Austin |
| State | TX |
| Country | United States |
| FEI number | 3002524000 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: