Aution Hybrid Au-4050 recall: Software Issue
AUTION HYBRID AU-4050
Why was Aution Hybrid Au-4050 recalled?
This correction is being initiated due to a software issue which results in the possibility of incorrect patient information being assigned to sample results when the following rare combination of three specific events were to occur: 1) No measurement results are generated due to an error by a urine sediment measurement. 2) The instrument is shutdown incorrectly. 3) An item rack is used for subsequent sample measurements.
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?
UDI: (01) 00015482146030 All serial numbers
- Product
- AUTION HYBRID AU-4050
- Recalling firm
- Arkray Factory USA, Inc.
- Quantity
- 159 units
- Distribution
- US
- Recall date
- June 26, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)