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U.S. Department of Health and Human Services

Class 2 Device Recall ABL800 Flex Series Analyzer

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  Class 2 Device Recall ABL800 Flex Series Analyzer see related information
Date Initiated by Firm January 18, 2008
Create Date June 25, 2015
Recall Status1 Terminated 3 on February 24, 2012
Recall Number Z-1654-2008
Recall Event ID 46686
510(K)Number K041874  
Product Classification Human Blood Analyzer - Product Code CHL
Product ABL800 FLEX Series Analyzer - Human Blood Analyzer (Laboratory Device)
Code Information ABL800 Flex (902-754)
Recalling Firm/
Manufacturer		 Radiometer America Inc
810 Sharon Dr
Westlake OH 44145-1598
For Additional Information Contact Vincent Sigmund
440-871-8900 Ext. 209
Manufacturer Reason
for Recall		 Reported calibration errors are not displayed on the analyzers parameter bar screen or on the patient results when the calibration number is between 32768 - 65535 and 98303 - 131070. This may cause the operator to perform measurements and obtain questionable results.
FDA Determined
Cause 2		 Software design
Action On February 28, 2008, a Field Action Notes Letter was issued advising them about a Mandatory Software Update. Customers were notified of the problem by fax and letter (Fed Ex). The Recall Letter instructed the user to disable the parameter bar feature and only rely on the traffic light system indicator which properly indicates system errors. The letter includes instructions to temporarily fix the problem and notice of a update of the software module that updates the parameter bar. If you have any questions contact Vincent Sigmund at (440)-871-8900 ext. 209.
Quantity in Commerce 2481
Distribution Worldwide Distribution - USA and Canada - Products were sold in all fifty (50) US States. including twenty-nine 29 government accounts and 138 Canadian accounts.
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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