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Showing 18761–18780 of 22584 results

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Smith & Nephew, Inc. Endoscopy Division: TruFit CB Plug Size Code Blue, 9mm; quantity 1; Part #605...

Mis-packaging-product in the package may be a different size than indicated on the labeling.

FDASep 29, 2006Nationwide• Smith & Nephew, Inc. Endoscopy Division

Smith & Nephew, Inc. Endoscopy Division: TruFit BGS Plug Size Code Blue, 9mm; quantity 1; Part #60...

Mis-packaging-product in the package may be a different size than indicated on the labeling.

FDASep 29, 2006Nationwide• Smith & Nephew, Inc. Endoscopy Division

Smith & Nephew, Inc. Endoscopy Division: TruFit BGS Plug Size Code Red, 7mm; quantity 1; Part #600...

Mis-packaging-product in the package may be a different size than indicated on the labeling.

FDASep 29, 2006Nationwide• Smith & Nephew, Inc. Endoscopy Division

Organogenesis, Inc.: Apligraf (Graftskin)

Product pH out of specification

FDASep 29, 2006Nationwide• Organogenesis, Inc.

Inverness Medical Professional Diagnostics: NOW Legionella Urinary Antigen Test. 22 test kit. For I...

Mislabeled product: Outer kit label reads NOW Legionella Urinary Antigen Test, inside contains S. pneumonia test pouches

FDASep 29, 2006Nationwide• Inverness Medical Professional Diagnostics

Ventana Medical Systems Inc: Benchmark LT, Slide Staining System, Catalog Number: N750...

Leaking Carboys/Safety Updates:The Ventana Staining Platform includes one or more carboys that may have the potential to leak if the spigot is either improperly installed or not fully closed.

FDASep 29, 2006Nationwide• Ventana Medical Systems Inc

Lifescan Inc: LifeScan brand OneTouch Sure Step- Blood Glucose Monitori...

Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results.

FDASep 29, 2006Nationwide• Lifescan Inc

Medrad Inc: Invasive Blood Pressure Interface Cables: a) Medrad 9500 ...

Interference problems: certain invasive blood pressure transducers connected to these cables are susceptible to interference if exposed to static magnetic field strengths exceeding 300 gauss. In certain orientations, the transducer causes the invasive blood pressure readings on the physiological monitor to display inaccurate readings.

FDASep 29, 2006CA, CO, HI +10 more• Medrad Inc

Ventana Medical Systems Inc: Benchmark XT, Slide Staining System, Catalog Number: N750...

Leaking Carboys/Safety Updates:The Ventana Staining Platform includes one or more carboys that may have the potential to leak if the spigot is either improperly installed or not fully closed.

FDASep 29, 2006Nationwide• Ventana Medical Systems Inc

Medrad Inc: Veris Invasive Blood Pressure Interface Cables-Part # 301...

Interference problems: certain invasive blood pressure transducers connected to these cables are susceptible to interference if exposed to static magnetic field strengths exceeding 300 gauss. In certain orientations, the transducer causes the invasive blood pressure readings on the physiological monitor to display inaccurate readings.

FDASep 29, 2006CA, CO, HI +10 more• Medrad Inc

Smith & Nephew, Inc. Endoscopy Division: TruFit CB Plug Size Code Red, 7mm; quantity 1; Part #605-...

Mis-packaging-product in the package may be a different size than indicated on the labeling.

FDASep 29, 2006Nationwide• Smith & Nephew, Inc. Endoscopy Division

Ventana Medical Systems Inc: Benchmark, Slide Staining System, Catalog Number: N750-BM...

Leaking Carboys/Safety Updates:The Ventana Staining Platform includes one or more carboys that may have the potential to leak if the spigot is either improperly installed or not fully closed.

FDASep 29, 2006Nationwide• Ventana Medical Systems Inc

Ventana Medical Systems Inc: Discovery XT, Slide Staining System, Catalog Number: N75...

Leaking Carboys/Safety Updates:The Ventana Staining Platform includes one or more carboys that may have the potential to leak if the spigot is either improperly installed or not fully closed.

FDASep 29, 2006Nationwide• Ventana Medical Systems Inc

Iris Sample Processing: StatSpin Express 3 Centrifuge with RTX8 Rotor Model: M502

Rotor may crack and separate causing device to fail. A failed rotor not successfully contained may seriously injure the laboratory worker.

FDASep 29, 2006Nationwide• Iris Sample Processing

Lifescan Inc: LifeScan brand One Touch -Sure Step Pro- Blood Glucose Mo...

Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results.

FDASep 29, 2006Nationwide• Lifescan Inc

Ventana Medical Systems Inc: Discovery, Slide Staining System, Catalog Number: N750-DI...

Leaking Carboys/Safety Updates:The Ventana Staining Platform includes one or more carboys that may have the potential to leak if the spigot is either improperly installed or not fully closed.

FDASep 29, 2006Nationwide• Ventana Medical Systems Inc

Arrow International Inc: Implantable Vascular Access System -- Infusion Ports with...

Catheter has separated from the infusion port body.

FDASep 29, 2006Nationwide• Arrow International Inc

Applied Biotech Inc: Clearview hCG Combo Waived for urine & Moderate for serum...

Sensitivity: Kits contain test devices which may not meet the label claims for sensitivity, therefore use of such devices may produce false negative results with patient samples at or near the limit of detection of the product.

FDASep 28, 2006Nationwide• Applied Biotech Inc

Lumiport, LLC: DermaStyle Chroma 2-blue and red light device indicated t...

Incorrect charger; batteries may overheat , catch fire or explode while being charged with the charger enclosed with the device.

FDASep 28, 2006OR• Lumiport, LLC

Applied Biotech Inc: Clearview hCG Combo with Reference Line, Wampole Laborato...

Sensitivity: Kits contain test devices which may not meet the label claims for sensitivity, therefore use of such devices may produce false negative results with patient samples at or near the limit of detection of the product.

FDASep 28, 2006Nationwide• Applied Biotech Inc

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