Reported Nov 14, 2012 · Terminated
ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable,…
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 CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point of care setting
- Lot codes and dates
- Serial Numbersall ABL80 FLEX CO-OX analyzers with sofware versions 1.30, 1.31, 1.32, 1.33, and 1.34
- Amount recalled
- 767 units
Where it was sold
Why it was recalled
The recall was initiated because SenDx Medical Inc. became aware of a software issue in the ABL80 FLEX CO-OX analyzer related to the reporting of the hemoglobin fractional parameters.
This product could cause temporary or reversible health problems — stop using it.
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