Device Recall ABL 800 FLEX analyzers 의 리콜

Recall

36812

Class 3

Z-1095-2007

2006-11-13

2007-07-24

Terminated

United States

2012-05-09

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49393

Software anomaly. protein removing program incorporated in the operating software for versions: v3.833 and v5.24, of the abl700 and abl800 blood gas analyzers, may allow for protein build up on the electrode membranes of blood gas analyzers. this condition can influence analyzer results. when the protein removal program is run too frequently, more than once a week, or when running the protein rem.

The firm issued a 'Safety Alert Notice' [FAN 915-248] to all customers which received the recalled ABL700 and ABL800 Analyzers equipped with the referenced software. The 11/13/2006 notice describes the problem concerning the Protein Removal program to the user/customers and emphasizes that the frequency of running the program in these software versions must be no more than once a week in order to prevent the protein build-up problem. It also contains additional recommendations for the user/customers for operation of these analyzer and informs the customers that a Radiometer Service Rep. will be coming out and making a software upgrade to these systems within the next few weeks. The alert notification is accompanied by a 'FAX FORM' to be signed and completed by each customer in order to verify that the alert notification has been received and that the staff members responsible for operating and maintaining the analyzer(s) on-site have been informed of this situation and that the necessary changes in the Operator's Manual concerning the Cleaning, Protein Removal, and Decontamination programs have been made.