Device 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.
Z-2304-2012
Product summary
- Event
- Event 60514
- Status
- Terminated
- Classification
- Class II
- Quantity
- ABL80 FLEX is 1680, ABL80 CO-OX is 1759
- Official record key
device-enforcement:Z-2304-2012
Official wording
Reason: 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.
Code information: Model Numbers: 393-839 (with 933-082 software) and 393-841 (with 933-132 software) All Serial Numbers
Distribution pattern: Worldwide Distribution - US Nationwide including the state of OH.
Derived failure modes
-
Unknown
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.