ARIES System and ARIES M1 System recall
ARIES System and ARIES M1 System
Why was ARIES System and ARIES M1 System recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
ARIES System UDI: 00840487101537 and ARIES M1 System UDI: 00840487100080
- Product
- ARIES System and ARIES M1 System
- Recalling firm
- Luminex Corporation
- Quantity
- 15 units
- Distribution
- Worldwide Distribution - US Distribution and to the countries of Finland and China.
- Recall date
- May 24, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)