Medical equipment, implants, and diagnostic devices
Becton Dickinson & Company
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
Aniara Diagnostica
Residual crystallization of the microplate and recurrent negative controls out of range.
Becton Dickinson &
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Becton Dickinson & Company
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.
Siemens Medical Solutions USA
Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.
Becton Dickinson & Company
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.
Becton Dickinson &
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Edwards Lifesciences
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
Becton Dickinson &
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.
Becton Dickinson &
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Siemens Healthcare Diagnostics
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
Becton Dickinson &
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Becton Dickinson &
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.
Siemens Medical Solutions USA
Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.
Becton Dickinson &
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Becton Dickinson & Company
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.