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U.S. Department of Health and Human Services

Class 2 Device Recall ARIES System, ARIES M1 System

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  Class 2 Device Recall ARIES System, ARIES M1 System see related information
Date Initiated by Firm June 29, 2018
Date Posted August 19, 2019
Recall Status1 Terminated 3 on April 28, 2021
Recall Number Z-2292-2019
Recall Event ID 81420
510(K)Number K151917  K160517  K162772  K161495  
Product Classification real time Nucleic acid amplification system - Product Code OOI
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
Code Information ARIES System UDI: 00840487101537  ARIES M1 System UDI: 00840487100080  ARIES-M12V1-IVD, ARIES System  ARIES-M6V1-IVD, ARIES M1 System CN-0321-01, ARIES System Handheld Barcode Scanner  All scanners manufactured after April 2017 and including Part Number JDK-2330 Rev B.
Recalling Firm/
Manufacturer		 Luminex Corporation
12212 Technology Blvd
Austin TX 78727-6101
For Additional Information Contact Wendy Ricker
608-203-8936
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action On July 10, 2018, the firm sent an "URGENT: FIELD SAFETY NOTICE" to customers via email (with a follow-up telephone call) informing them that they may have received an affected barcode scanner. The Notice explained that when the potentially affected barcode scanner is used on multiple ARIES¿ cassettes at the same time, the system may prepopulate the Sample ID field with a previously stored sample ID. This field will be overwritten by scanning or manually entering a sample, but in the event the ARIES cassette is not scanned, the prepopulated field may cause the incorrect association of sample identification to occur. The firm has conducted internal investigation that have shown that the firmware version on hand-held barcode scanner contained the incorrect version of firmware approved for use with the ARIES¿ Systems. Given that the ARIES¿ System barcode scanner (CN-0321-01 /JDK-2330 Rev B) has the potential to contribute to an incorrect result by creating the possibility that a Patient/Sample ID may be assigned to the wrong cassette, we are voluntarily initiating a recall to ensure no additional handheld scanners have this discrepant firmware. There have not been any adverse events associated with the use of the ARIES¿ System barcode scanners at this time. To confirm whether or not the customer's particular barcode scanner is affected, the firm is advising its customer to verify the firmware version of the handheld barcode scanner by following the attached instructions ("Confirming the Firmware Version on the ARIES Hand-Held Barcode Scanner") . An affected unit will include the labeling JDK-2330 Rev B on the underside of the scanner AND will have firmware version PAACES00-002-R03 or CAACES00-002-R03. Please contact Technical Support if you identify a discrepant barcode scanner model. Correct Model and Firmware (below) Model/Rev. Firmware Version JDK-2330 Rev B. PAACES00-001-R03 CAACES00-001-R03 If the in
Quantity in Commerce 153 (140 U.S. and 13 O.U.S.)
Distribution Worldwide distribution. US nationwide, Canada, Ireland, Netherlands, Singapore, Thailand, and United Kingdom
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OOI and Original Applicant = LUMINEX CORPORATION
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