Aug

2019

Recall – IVD Hand Held Barcode Scanner software error results in patient mismatch

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

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