CLASS II Device recall · Reported 28 Aug 2019 · FDA Enforcement Report

Aries M1 System recalled by Luminex

Luminex is recalling Aries M1 System, distributed nationwide in the US. The recall was initiated on 29 Jun 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesARIES 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.

Quantity recalled153 (140 U.S. and 13 O.U.S.)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2292-2019
FDA event ID: 81420
Recalling firm: Luminex, Austin, TX
Classification: Class II
Status: Terminated
Recall initiated: 29 Jun 2018
FDA classified: 19 Aug 2019
Reported: 28 Aug 2019
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Test Kits & Diagnostics

Timeline

29 Jun 2018	Recall initiated by company
19 Aug 2019	Classified by FDA	+416 days
28 Aug 2019	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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