Minneapolis, MN, United States
Arkray Factory USA, Inc. recalls
1 recall recorded since 2018, most recently on 3 May 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 3 May 2019
- Terminated
- 17 September 2020
- Reason
- 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.
- Distribution
- US
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1850-2019
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.