FDA Device

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

Hazard

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

What You Should Do

Remedy

The recalling firm issued letters dated 7/3/2018 on 7/3/2018 via FedEx.

Products

ABL800 analyzer, model numbers 393-800 and 393-801.
Brand
Radiometer America Inc
UPC
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.

Units Affected

2,131 analyzers