Z-0682-2019 Class II Terminated
FDA device recall Z-0682-2019 was initiated by Radiometer America Inc on July 3, 2018 and is designated Class II. Reason for recall: The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur. The recall status is terminated (terminated August 30, 2023). Affected quantity: 2,131 analyzers.
Recall Details
- Product Type
- Devices
- Report Date
- January 2, 2019
- Initiation Date
- July 3, 2018
- Termination Date
- August 30, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,131 analyzers
Product Description
ABL800 analyzer, model numbers 393-800 and 393-801.
Reason for Recall
The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.
Distribution Pattern
Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Canada.
Code Information
Model 393-800 ABL800 Series w/o Creatinin (All serial numbers) for the following configurations: ABL800, ABL805, ABL810, ABL815, ABL820, ABL825, ABL830, and ABL835. Model 393-801 ABL800 Series with Creatinin (All serial numbers) for the following configurations: ABL817, ABL827, and ABL837.