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U.S. Department of Health and Human Services

Class 2 Device Recall pH Blood Gas and Electrolytes Analyzer System

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  Class 2 Device Recall pH Blood Gas and Electrolytes Analyzer System see related information
Date Initiated by Firm June 06, 2012
Date Posted August 30, 2012
Recall Status1 Terminated 3 on September 04, 2012
Recall Number Z-2304-2012
Recall Event ID 60514
510(K)Number K051804  K080370  
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
Product ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System.

Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) are portable, automated analyzers that measure pH, blood gases, electrolytes, glucose and oximetry (ABL80 FLEX CO-OX only) in whole blood. The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) analyzer systems are intended for use by trained technologists, nurses, physicians and therapists. They are intended for use in a laboratory environment, near patient or point-of-care setting.
Code Information Model Numbers: 393-839 (with 933-082 software) and 393-841 (with 933-132 software) All Serial Numbers
Recalling Firm/
Manufacturer		 Sendx Medical Inc
1945 Palomar Oaks Way
Carlsbad CA 92011-1300
For Additional Information Contact
760-603-6300
Manufacturer Reason
for Recall		 The firm recalled because the glucose measurements from a patient sample that the customer felt was too low and did not reflect the patient's clinical condition.
FDA Determined
Cause 2		 Software design
Action Radiometer sent a Field Safety Notice letter dated June 06, 2012 via email to all affected customers. The letter identified the affected product, problem and actions to be taken. Also included is a Note to Users to be placed at the front of customers existing Operator's Manual. Customers were instructed to provide confirmation to Radiometer that all customers have received the letter and the Note to Users. For questions contact your Radiometer representative.
Quantity in Commerce ABL80 FLEX is 1680, ABL80 CO-OX is 1759
Distribution Worldwide Distribution - US Nationwide including the state of OH.
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 = SENDX MEDICAL, INC.
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