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U.S. Department of Health and Human Services

Class 3 Device Recall ABL 700 series analyzers

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 Class 3 Recall
ABL 700 series analyzers
see related information
Date Posted July 24, 2007
Recall Status1 Open
Recall Number Z-1094-2007
Recall Event ID 36812
Premarket Notification
510(K) Numbers
K002290  K041874 
Product Classification Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph - Product Code CHL
Product ABL 700 Series blood gas analyzers equipped with Software Version 3.833.
Code Information All serial numbers of the ABL 700 series containing software version 3.833.
Recalling Firm/
Manufacturer
Radiometer America Inc
810 Sharon Dr
Westlake, Ohio 44145-1598
For Additional Information Contact Vincent Sigmund
800-736-0600
Manufacturer Reason
for Recall
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
FDA Determined
Cause 2
DESIGN: Software Design
Action 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.
Quantity in Commerce 17
Distribution The recalled analyzers were distributed to customers nationwide throughout the U.S. and in some parts of Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CHL and Original Applicant = RADIOMETER MEDICAL A/S
510(K)s with Product Code = CHL and Original Applicant = RADIOMETER MEDICAL APS
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