Sendx Medical Inc recalls ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer Syst

Recalled September 5, 2012 · FDA recall Z-2304-2012 · Sendx Medical

Hazard

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 Class II

Units

ABL80 FLEX is 1680, ABL80 CO-OX is 1759

Sold at

Worldwide Distribution - US Nationwide including the state of OH.

Description

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.

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.

Manufacturer(s)

Sendx Medical Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →