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U.S. Department of Health and Human Services

Class 2 Device Recall Blood Gas and CoOx Electrolyte & Metabolyte Analyzers

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  Class 2 Device Recall Blood Gas and CoOx Electrolyte & Metabolyte Analyzers see related information
Date Initiated by Firm September 29, 2005
Date Posted August 10, 2006
Recall Status1 Terminated 3 on April 17, 2012
Recall Number Z-1386-06
Recall Event ID 34963
510(K)Number K002290  K992859  K991417  K980130  
Product Classification Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzers - Product Code JFP
Product Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers, ABL-700 Series, manufactured from 8/1998 through 11/2004.
Code Information All analyzers manufactured from 8/1998-11/2004, are subject to recall. The devices contain serial numbers 902-441RxxxNxxx. The Rxxx number denotes manufacturing run, and the Nxxx number denotes the individual instrument within the run.
Recalling Firm/
Manufacturer		 Radiometer America Inc
810 Sharon Dr
Westlake OH 44145-1598
For Additional Information Contact Vince Sigmund
800-736-0600
Manufacturer Reason
for Recall		 Under certain circumstances, the ABL 700 & 800 Series Blood Gas Analyzers may experience leakage current into the measuring system. Consequently, the analyzers intermittently provide incorrect (too low) result values for Calcium (Ca) and Sodium (Na).
FDA Determined
Cause 2		 Other
Action The consignees were notified of this recall by a letter, dated 9/29/2005. The letter informs the customers of this potential problem and the availability of new updated software which will correct the problem. The letter goes on to inform the customer that a Radiometer Service Engineer wil be contacting them shortly in order to arrange for a convenient time to install the software update. Along with the letter, the customer is provided a copy of an additional page and a CD concerning the function and operation of the new software, which is to be added to the customer''s Operator''s Manual.
Quantity in Commerce 1615 devices
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JFP and Original Applicant = RADIOMETER AMERICA, INC.
510(K)s with Product Code = JFP and Original Applicant = RADIOMETER MEDICAL A/S
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