Z-1850-2019 Class II Terminated
FDA device recall Z-1850-2019 was initiated by Arkray Factory USA, Inc. on May 3, 2019 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Sep 17, 2020). Affected quantity: 159 units.
Recall details
- Product Type
- Devices
- Report Date
- Jun 26, 2019
- Initiation Date
- May 3, 2019
- Termination Date
- Sep 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 159 units
Product description
AUTION HYBRID AU-4050
Reason for recall
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 pattern
US
Code information
UDI: (01) 00015482146030 All serial numbers
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1850-2019
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026