Recall Z-2094-2017
Luminex Corporation · initiated April 19, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ARIES System and ARIES M1 System
Codes / lots: ARIES System UDI: 00840487101537 and ARIES M1 System UDI: 00840487100080
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
A recall notification letter was sent out on April 19, 2017. Prior to the recall letter being sent, the recalling firm sent a Customer Advisory Notification on April 14, 2017. The firm is also adding an accountability form to the customer notifications in order to document the customer responses to ensure that we account for the estimated 15 distributed units. For further questions, please call (877) 785-2323.
Details
- Recall number
- Z-2094-2017
- Initiated
- April 19, 2017
- Terminated
- October 20, 2017
- Product code
- OOI – Real Time Nucleic Acid Amplification System
- Quantity
- 15 units
- Distribution
- Worldwide Distribution - US Distribution and to the countries of Finland and China.
- Recalling firm
- Luminex Corporation, Austin, TX