ARIES System and ARIES M1 System
Check against the official notice below — it lists the full affected range.
Luminex Corporation is recalling the hand-held barcode scanner accessory used with ARIES and ARIES M1 Systems. The scanner has a defect where it populates patient sample IDs with a previously scanned sample ID when entering orders into an ARIES instrument. This could result in patient samples being incorrectly identified. The recall affects 15 units that were distributed worldwide, including in the United States, Finland, and China.
The affected ARIES System has UDI 00840487101537 and the ARIES M1 System has UDI 00840487100080. The recall source does not specify what remedy consumers should pursue.
Written by software from the official notice below. Not reviewed by a lawyer.
The hand-held barcode scanner that is used as an accessory to enter ARIES cassette and specimen identifications on the ARIES Systems populates patient sample IDs with a previously scanned sample ID when entering orders into an ARIES instrument.
Reason for recall: The hand-held barcode scanner that is used as an accessory to enter ARIES cassette and specimen identifications on the ARIES Systems populates patient sample IDs with a previously scanned sample ID when entering orders into an ARIES instrument. Distribution: Worldwide Distribution - US Distribution and to the countries of Finland and China. Quantity: 15 units Lot/code info: ARIES System UDI: 00840487101537 and ARIES M1 System UDI: 00840487100080
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.