Z-2304-2012 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 5, 2012
- Initiation Date
- June 6, 2012
- Termination Date
- September 4, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- ABL80 FLEX is 1680, ABL80 CO-OX is 1759
Product Description
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.
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.
Distribution Pattern
Worldwide Distribution - US Nationwide including the state of OH.
Code Information
Model Numbers: 393-839 (with 933-082 software) and 393-841 (with 933-132 software) All Serial Numbers