Z-2094-2017 Class II Terminated
FDA device recall Z-2094-2017 was initiated by Luminex Corporation on April 19, 2017 and is designated Class II. 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 wh… The recall status is terminated (terminated October 20, 2017). Affected quantity: 15 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2017
- Initiation Date
- April 19, 2017
- Termination Date
- October 20, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 units
Product Description
ARIES System and ARIES M1 System
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 Pattern
Worldwide Distribution - US Distribution and to the countries of Finland and China.
Code Information
ARIES System UDI: 00840487101537 and ARIES M1 System UDI: 00840487100080