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Luminex Aries M1 System recallZ-2292-2019 · Luminex Corporation · initiated Jun 29, 2018

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Luminex Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Process control

What the company is doing

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

Recall details

Recall number
Z-2292-2019
Status
Terminated
Initiated by the company
Jun 29, 2018
Posted by the FDA
Aug 19, 2019
Recalling firm
Luminex Corporation
Quantity
153 (140 U.S. and 13 O.U.S.)
Product code
OOI
FDA submissions
K151917, K160517, K161495, K162772
Distribution
Worldwide distribution. US nationwide, Canada, Ireland, Netherlands, Singapore, Thailand, and United Kingdom

Product description

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 (models, lots, serial numbers)

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.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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