Radiometer America Inc recalls ABL800 analyzer, model numbers 393-800 and 393-801.
Recalled Product
ABL800 analyzer, model numbers 393-800 and 393-801.
Hazard / Issue
The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: 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.
View official government recall
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