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U.S. Department of Health and Human Services

Class 2 Device Recall ABL800 analyzer, model numbers 393800 and 393801

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  Class 2 Device Recall ABL800 analyzer, model numbers 393800 and 393801 see related information
Date Initiated by Firm July 03, 2018
Create Date December 22, 2018
Recall Status1 Terminated 3 on August 30, 2023
Recall Number Z-0682-2019
Recall Event ID 81547
510(K)Number K041874  
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
Product ABL800 analyzer, model numbers 393-800 and 393-801.
Code Information Model 393-800 ABL800 Series w/o Creatinin (All serial numbers) for the following configurations: ABL800, ABL805, ABL810, ABL815, ABL820, ABL825, ABL830, and ABL835.  Model 393-801 ABL800 Series with Creatinin (All serial numbers) for the following configurations: ABL817, ABL827, and ABL837. 
Recalling Firm/
Manufacturer		 Radiometer America Inc
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Technical Support
800-736-0600 Ext. 1
Manufacturer Reason
for Recall		 The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.
FDA Determined
Cause 2		 Software design
Action The recalling firm issued letters dated 7/3/2018 on 7/3/2018 via FedEx.
Quantity in Commerce 2,131 analyzers
Distribution Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Canada.
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 = CHL and Original Applicant = RADIOMETER MEDICAL APS
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