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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Event Detail

Event ID 60514
Product Type Devices
Status Completed
Recalling Firm Sendx Medical Inc
City Carlsbad
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-06
Initial Firm Notification of
Consignee or Public
E-Mail
Distribution Pattern Worldwide Distribution - US Nationwide including the state of OH.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Model Numbers: 393-839 (with 933-082 software) and 393-841 (with 933-132 software) All Serial Numbers Class II 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. ABL80 FLEX is 1680, ABL80 CO-OX is 1759 Z-2304-2012
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