Other Medical Devices

False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.

False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Battery packs may heat up abnormally and ignite in rare instance.

False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.

False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.

False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low progesterone result may lead to the consideration for additional progesterone supplementation.

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.