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
Check against the official notice below — it lists the full affected range.
Luminex Corporation is recalling 153 Luminex Aries M1 System Hand Held Barcode Scanners (140 in the U.S. and 13 internationally) distributed worldwide to Canada, Ireland, the Netherlands, Singapore, Thailand, and the United Kingdom. The scanners were manufactured after April 2017 and contain an incorrect control board and firmware that could cause sample or patient mix-ups or produce duplicate results from other patients' specimens in clinical laboratory testing.
The affected scanners have Part Number JDK-2330 Rev B and are used with ARIES System and ARIES M1 System devices. The source document does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: Worldwide distribution. US nationwide, Canada, Ireland, Netherlands, Singapore, Thailand, and United Kingdom Quantity: 153 (140 U.S. and 13 O.U.S.) Lot/code info: 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.