ABL800 analyzer, model numbers 393-800 and 393-801.

Reason: The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.

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.

Distribution pattern: Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Canada.