Z-0115-2007

Radiance Data Management System, Software Version 2.60, modification for the ABL800 Flex Blood Gas Analyzer

Name: Z-0115-2007 Radiance Data Management System, Software Version 2.60, modification for the ABL800 Flex Blood Gas Analyzer
Creator: Radiometer America Inc
Published: 2006-07-06
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2006-07-06 / Terminated

FDA source

Radiometer America Inc began a recall of Radiance Data Management System, Software Version 2.60, modification for the ABL800 Flex Blood Gas Analyzer on 2006-07-06. The reason FDA records is "Incorrect FI02 values: programming issue can cause incorrect values to be transmitted to the LIS when : 1)- The FIO2 result is edited in the manual sample processing mode--2)- An existing result is opened and FI02 is...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0115-2007
Status: Terminated
Initiated: 2006-07-06
Posted: 2006-10-28
Terminated: 2011-11-18
Recalling firm: Radiometer America, Inc
Product: Radiance Data Management System, Software Version 2.60, modification for the ABL800 Flex Blood Gas Analyzer
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Incorrect FI02 values: programming issue can cause incorrect values to be transmitted to the LIS when : 1)- The FIO2 result is edited in the manual sample processing mode--2)- An existing result is opened and FI02 is then edited and sent.....In both cases RADIANCE will transmit the original FI02 value, not the value that was edited.
FDA root cause: Other
Action: The recalling firm initially contacted their customers and informed them of the software problem and the upcoming field correction for the software, via telephone on 7/6/2006. A follow-up letter dated 7/21/2006, was also sent to the customers.
Quantity in commerce: 5 units
Distribution: Worldwide-The six USA units (equpped with Radiance software) were distributed to a total of two (2) U.S. customers: University of Missouri Hospitals and Clinics in Columbia, MO (4 units) and Vail Valley Medical Center, Vail, CO (2 units). World wide accounts pending submission. Three (3) Canadian customers. They are: 1) Seven Oaks General Hospital MB Canada; and 2) St. Mary''s General Hospital, 911 Queens Blvd, Ontario Canada; and 3) University of Alberta Hospital, 84440 112th Street, Alberta, Canada.
Product codes and lots: Catalog Numbers: 914-418 and 914-426

Product code JQP

K050869Class IIModification to Abl800 FlexRadiometer Medical Aps / cleared 2005-08-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)