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Recall Observatory FDA recall evidence

Device product

ARIES System and ARIES M1 System

Z-2094-2017

April 19, 2017

Class II

Product summary

Firm
Luminex Corporation
Event
Event 77052
Status
Terminated
Classification
Class II
Quantity
15 units
Official record key
device-enforcement:Z-2094-2017

Official wording

Reason: 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.

Code information: ARIES System UDI: 00840487101537 and ARIES M1 System UDI: 00840487100080

Distribution pattern: Worldwide Distribution - US Distribution and to the countries of Finland and China.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.