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U.S. Department of Health and Human Services

Class 2 Device Recall ABL90 FLEX Analyzer Radiometer Medical ApS

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  Class 2 Device Recall ABL90 FLEX Analyzer Radiometer Medical ApS see related information
Date Initiated by Firm October 15, 2013
Date Posted January 23, 2014
Recall Status1 Terminated 3 on June 19, 2014
Recall Number Z-0816-2014
Recall Event ID 66875
510(K)Number K092686  
Product Classification Electrode, ion specific, sodium - Product Code JGS
Product ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21
Br¿nsh¿j, Denmark
A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
Code Information Lot R0375N009, Model #393-090, S/N 393-090R0027N001 - 393-090R0379N010
Recalling Firm/
Manufacturer		 Radiometer America Inc
810 Sharon Dr
Westlake OH 44145-1521
For Additional Information Contact Radiometer America Technical Support
440-871-8900 Ext. 4
Manufacturer Reason
for Recall		 RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium (Na+) results.
FDA Determined
Cause 2		 Other
Action Radiometer sent an Urgent Medical Device Recall letter dated November 5, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check all of their ABL90 FLEX analyzers and ensure that the analyzer is placed on a horizontal platform/table. If the analyzer is placed on a roll stand, please ensure that the support plate is aligned horizontally and locked in this position. Customers were asked to complete and fax the accompanying acknowledgment form in order to confirm their receipt of this field safety notice. Customers with questions were instructed to contact Radiometer America Technical Support at 1-800-736-0600, option 4. For questions regarding this recall call 440-871-8900.
Quantity in Commerce Total 3414 (US 524, CA 31, ROW 2859)
Distribution Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI & WV and Internationally to Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Netherlands, Norway, Poland, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey & 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 = JGS and Original Applicant = RADIOMETER MEDICAL APS
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