FDA-Device2019-01-02Class II
ABL800 analyzer, model numbers 393-800 and 393-801.
Radiometer America Inc
Hazard
The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.
Sold states
Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Canada.
Affected count
2,131 analyzers
Manufactured in
250 S Kraemer Blvd, Brea, CA, United States
Products
ABL800 analyzer, model numbers 393-800 and 393-801.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0682-2019Don't want to check this manually?
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