All Recalls

Mislabeling - Some unit of sale packages (bags of 100 sets of MPC-125) were found to be incorrectly labeled as Molded Products Male to Male Luer Adapters, Catalog # MPC-150.

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 action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures

The anti-tip tubes potentially fail in certain situations and the wheelchairs can tip backwards.

Software Security; The action is being initiated because of software security vulnerabilities with the firm's analyzer operating system, which may cause the device to shutdown or reboot resulting in delayed medical treatment.

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.

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.

Iincreased (falsely elevated) Albumin results compared to expected results

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.

Residual crystallization of the microplate and recurrent negative controls out of range.

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.

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 action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures

Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage