Company: Luminex Corporation
Date of Enforcement Report: 8/28/2019
Class II
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.
- Recall Number: Z-2292-2019
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/MANUFACTURER
Luminex Corporation on 6/29/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
153 (140 U.S. and 13 O.U.S.)
DISTRIBUTION
US Nationwide and International