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

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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Corporate Office

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USA
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