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U.S. Department of Health and Human Services

Class 2 Device Recall ABL90 Flex

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  Class 2 Device Recall ABL90 Flex see related information
Date Initiated by Firm January 26, 2017
Create Date March 14, 2017
Recall Status1 Terminated 3 on February 20, 2018
Recall Number Z-1462-2017
Recall Event ID 76339
510(K)Number K092686  
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
Product ABL90 Flex
Model #: 393-090

Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood.
Code Information The affected analyzers are serial numbers 393-090R0027N001 to present.
Recalling Firm/
Manufacturer		 Radiometer America Inc
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Radiometer America Technical Support
440-871-0463
Manufacturer Reason
for Recall		 Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.
FDA Determined
Cause 2		 Device Design
Action Customer notification letters were sent 01/27/16. The letter provided the following instructions: The firm recommends that customers ensure that operators and clinicians using the "cord blood sample results from a HIS/LIS or a middleware system to determine treatment are made aware that arterial or venous is not transmitted. An upgraded version of the ABL90 and ABL800 series software will ensure that the full sample type cord blood arterial and cord blood venous will be transmitted to the HIS/LIS or middleware system. The new software version will be installed by local engineer when available. If not the end user customers are instruction to provide a copy of the recall notification letter to the end user. Any questions regarding this letter contact Radiometer America Technical Support at 1-800-736-0600 opt.1.
Quantity in Commerce 9,688
Distribution U.S. distribution to the following; nationwide. Foreign distribution to the following; Netherlands, China, Czech Republic, Denmark, Germany, Spain, France, Hungary, India, Japan, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland.
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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