Radiometer America Inc ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21.
Brand
Radiometer America Inc
Lot Codes / Batch Numbers
All ABL800 analyzers running software vers 5.21 i.e. ABL8xx 754R00xx N0xx
Products Sold
All ABL800 analyzers running software vers 5.21 i.e. ABL8xx 754R00xx N0xx
Radiometer America Inc is recalling ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21. due to ABL800 Series Blood Gas Analyzer became inoperable when the 'restore default setup' button was touched.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
ABL800 Series Blood Gas Analyzer became inoperable when the 'restore default setup' button was touched.
Recommended Action
Per FDA guidance
The firm initiated this recall on 10/31/2005, at which time a Field Action Note was issued to their Service Reps. The notice instructed the service personnel to upgrade all ABL800 analyzer units presently running with software version V5.21 to the new version V5.23, in order to correct this problem. The Service Personnel began conducting visits at each customer site on 10/31/2005.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026