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Showing 61781–61800 of 68218 results

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Bio-Rad Laboratories: Rubella IgG EIA test kit, containing 1 Rubella IgG Microp...

Elevated optical density (OD) values with the kit Negative Control.

FDAAug 20, 2008Nationwide• Bio-Rad Laboratories

Siemens Medical Solutions USA, Inc.: Siemens Ultrasound, Acuson/Sonovista X300 ultrasound syst...

Incorrect value calculations by the device may result in inaccurate aortic stenosis estimates.

FDAAug 19, 2008PR• Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc.: Siemens Ultrasound, Acuson/Sonovista X300 ultrasound syst...

Thermal Index cranial (TIC) is not displayed for the Neo-Head exam type with the C8-5 transducer. This is a required display to support the alara principle when imaging cranial structure.

FDAAug 19, 2008Nationwide• Siemens Medical Solutions USA, Inc.

Zimmer Inc.: Orthosoft Navitrack, OS Unicondylar Knee 1.0 - Universal;...

Incorrect parameters: If the user switches from one surgeon profile to another surgeon profile after completing anatomical landmark acquisition tasks, the application will continue to use the initial surgeon profile parameter values in the calculation of the predicted hip-knee-ankle alignment estimates, which may have different resection or component thickness parameters than are appropriate for

FDAAug 19, 2008Nationwide• Zimmer Inc.

Zeus Scientific Inc: Sm ELISA Test System Product number 2Z2831G and Product n...

The Calibrator Value is printed incorrectly on the Sm ELISA Test System, lot # 08041819. The Calibrator Value (CV) printed on the label is 102; the correct CV should read 266.

FDAAug 19, 2008Nationwide• Zeus Scientific Inc

Mainline Technology, Inc.: Mainline Confirms III Serum/Urine control set, Mainline T...

Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates.

FDAAug 18, 2008Nationwide• Mainline Technology, Inc.

Mainline Technology, Inc.: Mainline hCG Accuracy Check, Mainline Technologies, Inc.,...

Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates.

FDAAug 18, 2008Nationwide• Mainline Technology, Inc.

Stryker Spine: Reflex Hybrid 4.0 x 14 mm Variable, Self-Tapping Bone Scr...

The Reflex Hybrid 4.0 x 14 mm Variable, Self Tapping Bone Screw, Lot NSZ, was determined to have been anodized with the incorrect color for that screw.

FDAAug 18, 2008Nationwide• Stryker Spine

Mainline Technology, Inc.: Mainline Confirms Strep A, Mainline Technologies, Inc., A...

Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates.

FDAAug 18, 2008Nationwide• Mainline Technology, Inc.

Stryker Spine: Ray TFC Device with End Caps: Single Patient use; Sterile...

The label on one side on the Ray TFC Device (Ray Cage) is incorrect. It reads 20 mm x 26 mm instead of 20 mm x 21 mm.

FDAAug 18, 2008Nationwide• Stryker Spine

Mainline Technology, Inc.: f.y.i. hCG Urine one-step pregnancy test, Carmel Diagnost...

Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates.

FDAAug 18, 2008Nationwide• Mainline Technology, Inc.

Mainline Technology, Inc.: Mainline Confirms hCG urine pregnancy test, Mainline Tech...

Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates.

FDAAug 18, 2008Nationwide• Mainline Technology, Inc.

Mainline Technology, Inc.: Mainline Confirms Strep A DOTS, Mainline Technologies, In...

Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates.

FDAAug 18, 2008Nationwide• Mainline Technology, Inc.

Mainline Technology, Inc.: Mainline Confirms hCG Serum/Urine III, Mainline Technolog...

Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates.

FDAAug 18, 2008Nationwide• Mainline Technology, Inc.

GE Medical Systems, LLC: Sterile, Drape, Headset, Upper, Part Number 888945-01.

GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have seals that could be compromised during the shelf life of the products. This issue could result in the product not maintaining its sterile state. Eleven complaints and 3 MDR's have been filed. No illness or injuries reported.

FDAAug 15, 2008Nationwide• GE Medical Systems, LLC

GE Medical Systems, LLC: Disposable Pack, Headset Part Number 888946-01(kit includ...

GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have seals that could be compromised during the shelf life of the products. This issue could result in the product not maintaining its sterile state. Eleven complaints and 3 MDR's have been filed. No illness or injuries reported.

FDAAug 15, 2008Nationwide• GE Medical Systems, LLC

Philips Medical Systems North America Co. Phillips: Essenta DR is a digital multifunctional X-ray systems, su...

When a patient is selected in the patient list and examination tab pressed with background query running at the same time, the wrong patient may be selected.

FDAAug 15, 2008Nationwide• Philips Medical Systems North America Co. Phillips

GE Medical Systems, LLC: Sterile, Drape, Headset, Lower, Part Number 888944-01.

GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have seals that could be compromised during the shelf life of the products. This issue could result in the product not maintaining its sterile state. Eleven complaints and 3 MDR's have been filed. No illness or injuries reported.

FDAAug 15, 2008Nationwide• GE Medical Systems, LLC

GE Medical Systems, LLC: GE Medical Systems, OEC, Vascular Drape, 00-902776-01, St...

GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have seals that could be compromised during the shelf life of the products. This issue could result in the product not maintaining its sterile state. Eleven complaints and 3 MDR's have been filed. No illness or injuries reported.

FDAAug 15, 2008Nationwide• GE Medical Systems, LLC

Stryker Howmedica Osteonics Corp.: Stryker Osteosynthesis Reduction Spoon; 1 single unit to ...

Stryker has become aware of the potential for breakage of the Reduction Spoon designed prior to 2003.

FDAAug 14, 2008Nationwide• Stryker Howmedica Osteonics Corp.

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