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Showing 67341–67360 of 68218 results

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Diagnostic Products Corp: IMMULITE 2000 Intact PTH kit

High bias noted in samples collected with EDTA. Indication is to not run samples with EDTA.

FDAFeb 23, 2004CO, CT, MO +3 more• Diagnostic Products Corp

Genzyme Diagnostics: Giardia/ Cryptosporidium Rapid In-vitro diagnostic Test k...

False Positive results.

FDAFeb 23, 2004MD, OH• Genzyme Diagnostics

Baxter Healthcare Renal Div: Baxter Arena Hemodialysis Delivery System; Baxter Healthc...

These devices have the potential to overheat in the absence of a Ground Fault Circuit Interrupter (GFCI). This heater system failure could result in a fire.

FDAFeb 20, 2004Nationwide• Baxter Healthcare Renal Div

Baxter Healthcare Renal Div: Baxter System 1000 Single Patient Hemodialysis Delivery S...

These devices have the potential to overheat in the absence of a Ground Fault Circuit Interrupter (GFCI). This heater system failure could result in a fire.

FDAFeb 20, 2004Nationwide• Baxter Healthcare Renal Div

Cryolife Inc: CryoValve, Aortic Valve & Conduit

Microorganisms were detected in donor tissue associated with this allograft, specifically Aeormonas hydrophila.

FDAFeb 20, 2004CA, IN• Cryolife Inc

Eastman Kodak Co: Kodak DirectView DR 7100 System, Catalog #133-6049, a dig...

Defective component in overhead tube support balancer may cause the suspended load to fall.

FDAFeb 20, 2004Nationwide• Eastman Kodak Co

Spencer Technologies, Inc.: Transcranial Doppler Ultrasound System with 2 MHz Transdu...

Potential for saved blood flow velocity values to not agree with actual velocity values as shown on the spectrogram axis.

FDAFeb 19, 2004Nationwide• Spencer Technologies, Inc.

Smith And Nephew, Inc. Endoscopy Division: Endocoupler 18 MM F.L, Autoclavable Catalog Number: 7207...

Endocouplers assembled with screws that cannot be effectively sterilized

FDAFeb 19, 2004AL, AZ, CA +16 more• Smith And Nephew, Inc. Endoscopy Division

Smith And Nephew, Inc. Endoscopy Division: Endocoupler , C-Mount 35 mm Focal Length Catalog Number:...

Endocouplers assembled with screws that cannot be effectively sterilized

FDAFeb 19, 2004AL, AZ, CA +16 more• Smith And Nephew, Inc. Endoscopy Division

Burton Medical Products Corp: All Outpatient and Coolspot single ceiling or single trac...

Pivot joint on these ceiling mount lights may fail and lights may fall onto patients.

FDAFeb 19, 2004Nationwide• Burton Medical Products Corp

Vysis: ProbeChek Vysis UroVysion Control Slides, for Fluorescenc...

Some of the control slides did not have adequate cells deposited upon their surface.

FDAFeb 19, 2004AZ, AR, CA +19 more• Vysis

Smith And Nephew, Inc. Endoscopy Division: Endocpir, Zoom for Dyonics 3-Chip Camera Catalog Number:...

Endocouplers assembled with screws that cannot be effectively sterilized

FDAFeb 19, 2004AL, AZ, CA +16 more• Smith And Nephew, Inc. Endoscopy Division

Smith And Nephew, Inc. Endoscopy Division: Endocoupler, C-Mount 30 mm Focal Length Catalog Number: ...

Endocouplers assembled with screws that cannot be effectively sterilized

FDAFeb 19, 2004AL, AZ, CA +16 more• Smith And Nephew, Inc. Endoscopy Division

Smith And Nephew, Inc. Endoscopy Division: Endocoupler C-Mount 35 mmFocal Length Catalog Number: 69...

Endocouplers assembled with screws that cannot be effectively sterilized

FDAFeb 19, 2004AL, AZ, CA +16 more• Smith And Nephew, Inc. Endoscopy Division

Binax, Inc.: NOW RSV Test Item Number 430-430, Kit Number 430-00R

Pouch integrity compromised

FDAFeb 18, 2004KS• Binax, Inc.

Binax, Inc.: NOW Malaria (Export use only) Item Number 660-430, Kit N...

Pouch integrity compromised

FDAFeb 18, 2004KS• Binax, Inc.

Cryolife Inc: CryoValve, Aortic Valve and Conduit

CryoLife received additional information after release of tissue indicating the donor had repeatedly reactive test results for antibody to HCV (EIA) in 1995.

FDAFeb 18, 2004TX, DC• Cryolife Inc

ATS Medical, Inc.: ATS Open Pivot Mechanical Heart Valve

Normally functioning prosthesis may have been placed on the valve holder mechanism in reverse position.

FDAFeb 18, 2004Nationwide• ATS Medical, Inc.

Arrow International Inc: Two Lumen 14F Hemodialysis Catheter Kits/Sets with Blue F...

catheter slips out of the suture wing during use.

FDAFeb 18, 2004Nationwide• Arrow International Inc

Binax, Inc.: NOW Filariasis Rapid test for W. bancrofti antigen. (Expo...

Pouch integrity compromised

FDAFeb 18, 2004KS• Binax, Inc.

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