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Radiometer America Inc recalls ABL800 analyzer, model numbers 393-800 and 393-801.
Recalled January 2, 2019 · FDA recall Z-0682-2019 · Radiometer America
Hazard
The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur. · FDA Class II
Units
2,131 analyzers
Sold at
Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Canada.
Description
The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.
Product
ABL800 analyzer, model numbers 393-800 and 393-801.
Manufacturer(s)
Radiometer America Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →