All Recalls

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

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

Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers.

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 action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values based on PW Doppler are calculated normally but not loaded correctly into hardware

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.

An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners could result in sample/patient mismatch or duplicate results (from other patients specimens) for a patient order.

Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.

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 action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values based on PW Doppler are calculated normally but not loaded correctly into hardware

The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values based on PW Doppler are calculated normally but not loaded correctly into hardware

Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.

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

Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently seated, it renders the device nonfunctional because the Outflow Graft connection will leak during the implant procedure.

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

Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.