Luminex Corporation: 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

Recalling firm

Luminex Corporation

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

Status

Terminated

Initiated

2018-06-29

Posted

2019-08-19

Terminated

2021-04-28

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.

Root cause

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

153 (140 U.S. and 13 O.U.S.)

Distribution

Worldwide distribution. US nationwide, Canada, Ireland, Netherlands, Singapore, Thailand, and United Kingdom

Lot, serial or model codes

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.

510(k) numbers

["K151917","K160517","K161495","K162772"]

PMA numbers

not on file

Product code

OOI

Firm FEI

3002524000

Firm city

Austin

Firm state

TX

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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