Recall Z-2292-2019— Luminex Corporation
Class II · Terminated
Class II FDA medical device recall by Luminex Corporation, initiated 2018-06-29, terminated 2021-04-28. It names 4 FDA 510(k) clearances: K162772, K161495, K160517 and 1 more. 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: 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..
- Recalling firm
- Luminex Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-29
- Terminated
- 2021-04-28
- Firm location
- Austin, TX, United States
510(k) clearances named in this recall
4 on FDA's record- K162772 — ARIES GBS Assay
- K161495 — ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)
- K160517 — ARIES System
- K151917 — ARIES System
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.