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Showing 18081–18100 of 22584 results

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Meretek Diagnostics, Inc.: BreathTek Urea Hydrolysis Rate Calculation CD, Version 1....

Diagnostic test kit for Helicobacter pylori was distributed for adult and pediatric use, but was not approved for pediatric use.

FDAMay 2, 2007Nationwide• Meretek Diagnostics, Inc.

Ross Products Division Abbott Laboratories: Patrol enteral pump set with piercing pin, list #520540.

The enteral pump set may have a 1-3 mm slit in the silicone tubing located between the blue connector and the stretch band Safe-T-Valve.

FDAMay 2, 2007Nationwide• Ross Products Division Abbott Laboratories

Gen-Probe Inc: Accuprobe Group B Streptococcus Culture Identification Te...

Mispackaging: Kits may contain Haemophilus Influenza probe pouches in addition to Group B Streptococcus probe pouches

FDAMay 2, 2007Nationwide• Gen-Probe Inc

Boston Scientific Corporation One Boston: Boston Scientific Scimed Maverick 2 Monorail" PTCA Cath...

The units within this lot may not meet thickness specifications surrounding the wire exit port wall, which may result in an air embolization if the Port Septum Wall burts.

FDAMay 1, 2007Nationwide• Boston Scientific Corporation One Boston

Boston Scientific Corporation One Boston: Boston Scientific NexStent Monorail 5F Carotid Stent and...

Boston Scientific NexStent Carotid Stent device failed to deploy when the outer catheter (proximal outer and distal sheath) did not pull back and expose the self-expanding stent.

FDAMay 1, 2007Nationwide• Boston Scientific Corporation One Boston

Dental Equipment LLC: DCI Equipment Track Mount Light Assembly, 110v

Potential for light shield to melt due to light assemblies not properly rated to handle the VAC.

FDAMay 1, 2007IN, NY• Dental Equipment LLC

Possis Medical, Inc: Angiojet XMI Rapid Exchange, catheters, 135 cm, 4 F, Sin...

Mislabeling: XMI (OTW) catheters were mislabeled as XMI-RX units and AVX catheters were mislabeled as Spiroflex catheters.

FDAMay 1, 2007Nationwide• Possis Medical, Inc

Possis Medical, Inc: Angiojet Spiroflex, Catheter, 135 cm, 4F, Single use onl...

Mislabeling: XMI (OTW) catheters were mislabeled as XMI-RX units and AVX catheters were mislabeled as Spiroflex catheters.

FDAMay 1, 2007Nationwide• Possis Medical, Inc

Roche Diagnostics Corp.: Roche VANC2, Online TDM Vancomycin, for use with the Roch...

Probe Wash: Reported results may have a positive bias because inadequate analyzer probe wash instructions may result in carry-over from the following assays: Creatinine Kinase L and Creatine Kinase-MBL.

FDAApr 30, 2007Nationwide• Roche Diagnostics Corp.

Philips Medical Systems North America Co. Phillips: Panorama 1.0T MRI

Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the MRI site.

FDAApr 30, 2007Nationwide• Philips Medical Systems North America Co. Phillips

Philips Medical Systems North America Co. Phillips: Intera MRI

Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the MRI site.

FDAApr 30, 2007Nationwide• Philips Medical Systems North America Co. Phillips

Siemens Medical Solutions USA, Inc.: c.cam Gamma Camera, Model 9VIR1200; Siemens Medical Solut...

Chair Breakage: Under extreme load, the chair back of the c.cam emission computed tomography system may bend and eventually break. This could be caused by the accumulated stress from heavy patients seating or stretching themselves in the chair or simply from long time use.

FDAApr 30, 2007Nationwide• Siemens Medical Solutions USA, Inc.

Philips Medical Systems North America Co. Phillips: Gyroscan MRI

Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the MRI site.

FDAApr 30, 2007Nationwide• Philips Medical Systems North America Co. Phillips

Abbott Laboratories, Inc: ARCHITECT i2000 Processing Module, for in vitro diagnosti...

One or more of four software issues : 1) calculation error for Architect cSystem assays using the Spline math model. 2) The system configuration option, Run controls onboard reagents by Kit, does not function correctly for assays requiring a standard sample dilution. 3) Infrequent data may be missing from automatically or manually printed reports generated on the Architect system. 4) Clinical Chem

FDAApr 30, 2007PR• Abbott Laboratories, Inc

Roche Diagnostics Corp.: Roche VALP2, Online TDM Valproic acid , for use with the ...

Probe Wash: Reported results may have a positive bias because inadequate analyzer probe wash instructions may result in carry-over from the following assays: Creatinine Kinase L and Creatine Kinase-MBL.

FDAApr 30, 2007Nationwide• Roche Diagnostics Corp.

Ciba Vision Corporation: CIBASoft Visitint Soft Contact Lenses, SKU #749591001385,...

Base curve of the lenses do not meet specification.

FDAApr 30, 2007Nationwide• Ciba Vision Corporation

Abbott Laboratories, Inc: ARCHITECT i2000sr Processing Module, for in vitro diagnos...

One or more of four software issues : 1) calculation error for Architect cSystem assays using the Spline math model. 2) The system configuration option, Run controls onboard reagents by Kit, does not function correctly for assays requiring a standard sample dilution. 3) Infrequent data may be missing from automatically or manually printed reports generated on the Architect system. 4) Clinical Chem

FDAApr 30, 2007PR• Abbott Laboratories, Inc

Philips Medical Systems North America Co. Phillips: Achieva MRI

Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the MRI site.

FDAApr 30, 2007Nationwide• Philips Medical Systems North America Co. Phillips

Abbott Laboratories, Inc: ARCHITECT c8000 Processing Module, for in vitro diagnosti...

One or more of four software issues : 1) calculation error for Architect cSystem assays using the Spline math model. 2) The system configuration option, Run controls onboard reagents by Kit, does not function correctly for assays requiring a standard sample dilution. 3) Infrequent data may be missing from automatically or manually printed reports generated on the Architect system. 4) Clinical Chem

FDAApr 30, 2007PR• Abbott Laboratories, Inc

Abbott Laboratories, Inc: ARCHITECT c16000 Processing Module, for in vitro diagnost...

One or more of four software issues : 1) calculation error for Architect cSystem assays using the Spline math model. 2) The system configuration option, Run controls onboard reagents by Kit, does not function correctly for assays requiring a standard sample dilution. 3) Infrequent data may be missing from automatically or manually printed reports generated on the Architect system. 4) Clinical Chem

FDAApr 30, 2007PR• Abbott Laboratories, Inc

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