Reported Sep 5, 2012 · Terminated
ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer…
Sendx Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sendx Medical Inc · 1945 Palomar Oaks Way · Carlsbad, CA · 92011-1300
Is this the product you have?
- 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.
- Lot codes and dates
- Model Numbers393-839 (with 933-082 software) and 393-841 (with 933-132 software) All Serial Numbers
- Amount recalled
- ABL80 FLEX is 1680, ABL80 CO-OX is 1759
Where it was sold
- Nationwide
- OH
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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