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U.S. Department of Health and Human Services

Class 2 Device Recall ABL90 FLEX Blood Analyzer

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  Class 2 Device Recall ABL90 FLEX Blood Analyzer see related information
Date Initiated by Firm November 01, 2010
Date Posted February 02, 2011
Recall Status1 Terminated 3 on May 09, 2012
Recall Number Z-1011-2011
Recall Event ID 57275
510(K)Number K092686  
Product Classification Potassium Ion Specific Electrode - Product Code CEM
Product ABL90 FLEX Blood Analyzer Part Number: 393-090.

Intended for use by trained technologists, nurses, physicians and therapists and for use in a laboratory environment, near patient or point-of-care setting. Also, Intended for in vitro testing of samples of heparinized whole blood.
Code Information S/N 393-090R0059N007, 393-090R0061N008 & 393-090R0061N009
Recalling Firm/
Manufacturer		 Radiometer America Inc
810 Sharon Dr
Westlake OH 44145
For Additional Information Contact
440-871-8900 Ext. 209
Manufacturer Reason
for Recall		 Due to a software error, a patient mix up can occur on the ABL90. If a sample is pre-registered and the sample "fails" the next result will inherit the patient data from the previous result.
FDA Determined
Cause 2		 Software design
Action On 11/16/10 the firm sent Medical Device Field Correction letters to their customers. The letter states that all systems will be upgraded and until each system is upgraded, they instructed their customer to "always query for patient ID prior to introducing the sample." They also instruct each customer to complete the "Fax Return Form" acknowledging receipt of the letter. If customers have questions regarding the letter or the upgrade, they should contact Technical Support at 1-800-736-0600 Opt 4.
Quantity in Commerce 432 units
Distribution Worldwide Distribution -- USA, including states of MI, NJ, & PA and countries Australia, Austria, Belgium, Denmark, Finland, France, Germany, Indonesia, Italy, Japan, Kuwait, Malaysia, Netherlands, Norway, Poland, Russia, Spain, Sweden, Switzerland, United Arab Emirates & United Kingdom.
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 = CEM and Original Applicant = RADIOMETER MEDICAL APS
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