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Showing 67861–67880 of 68218 results

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Coopervision Inc: Frequency 55 Toric (methafilcon B), flexible wear contact...

Mislabeled with incorrect sphere power.

FDAJul 22, 2003Nationwide• Coopervision Inc

Abbott Laboratories HPD/ADD/GPRD: IMx Rubella IgM Reagent Kit, 100 tests, list 7A24-20; Abb...

The package insert contains incomplete information for the English text. Pages 4 and 5 are missing and pages 14 and 15 are duplicated.

FDAJul 22, 2003CA, GA, IL +8 more• Abbott Laboratories HPD/ADD/GPRD

Misys Healthcare Systems: Misys Laboratory System versions 5.2 through 5.3.2 using ...

Software design deficiency. If the dilution factor is added to the same result twice, incorrect specimen values are reported.

FDAJul 22, 2003Nationwide• Misys Healthcare Systems

Becton Dickinson & Co.: Becton Dickinson's ProbeTec (tm) ET Instrument

Component of in vitro diagnostic device was incorrectly installed causing incorrect reporting of patient results.

FDAJul 21, 2003Nationwide• Becton Dickinson & Co.

Abbott Vascular Devices: BiodivYsio SV Over The Wire (OTW) Coronary Stent, 2.25 mm...

The medical device is misbranded in that the compliance chart of the Stent diameter may allow overexpansion that may result in vessel damage.

FDAJul 21, 2003Nationwide• Abbott Vascular Devices

Misys Healthcare Systems: Misys Laboratory System, versions 5.3 build 63 through 5....

Incorrect demographics display which can result in incorrect information being used in diagnosis or treatment of patients.

FDAJul 21, 2003Nationwide• Misys Healthcare Systems

Roche Diagnostics Corp.: Disetronic H-TRON V100 Insulin Pump; catalog # 8010030C [...

Lack of assurance of reliability, due to quality system regulations violations, plus notice to users not to expose pump to water.

FDAJul 21, 2003Nationwide• Roche Diagnostics Corp.

Alcon Laboratories, Inc.: ''Alcon Ladarwave CustomCornea Wavefront System'' Aberrom...

Software error could, under specific circumstances, allow the patient's centration images and data to be stored incorrectly.

FDAJul 21, 2003Nationwide• Alcon Laboratories, Inc.

Perkinelmer Life Sciences, Inc.: Anti-dsDNA [125I] Radiobinding Assay Kit. For In-Vitro Di...

Product's outer carton label was labeled with an extended expiration date

FDAJul 21, 2003CA, IN, MO +1 more• Perkinelmer Life Sciences, Inc.

Roche Diagnostics Corp.: Disetronic H-TRONplus Insulin Pump; catalog # 8050023 [cl...

Lack of assurance of reliability, due to quality system regulations violations, plus notice to users not to expose pump to water.

FDAJul 21, 2003Nationwide• Roche Diagnostics Corp.

Varian, Inc.: On-Site Alcohol IVD A single use enzymatic assay for qua...

Stability in question.

FDAJul 18, 2003Nationwide• Varian, Inc.

Philips Medical Systems Sales & Service Region No. America: Diagnost 97

Labeling of push button caps located on the control panel may not clearly identify the applied Source to Image distance (SID).

FDAJul 17, 2003Nationwide• Philips Medical Systems Sales & Service Region No. America

Philips Medical Systems Sales & Service Region No. America: OmniDiagnost System

Labeling of push button caps located on the control panel may not clearly identify the applied Source to Image distance (SID).

FDAJul 17, 2003Nationwide• Philips Medical Systems Sales & Service Region No. America

Stryker Howmedica Osteonics: Femoral Resection Guide, Scorpio L.R.S. Instrumentation.

Scorpio Femoral Resection Guides have the potential to remove more bone than necessary.

FDAJul 17, 2003IN• Stryker Howmedica Osteonics

Baxter Healthcare Corp. Rt: Vented Solution Set, 10 drops/mL, 92'', Luer Activated Va...

There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.

FDAJul 16, 2003Nationwide• Baxter Healthcare Corp. Rt

Baxter Healthcare Corp. Rt: Interlink System Solution Set with Microbore Tubing, 60 D...

There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.

FDAJul 16, 2003Nationwide• Baxter Healthcare Corp. Rt

Baxter Healthcare Corp. Rt: Fenwal Blood Component Recipient Set with Standard Blood ...

There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.

FDAJul 16, 2003Nationwide• Baxter Healthcare Corp. Rt

Baxter Healthcare Corp. Rt: Baxter Vented Nitroglycerin Set, 105'', PVC Tubing Segmen...

There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.

FDAJul 16, 2003Nationwide• Baxter Healthcare Corp. Rt

Baxter Healthcare Corp. Rt: Fenwal Straight Type Blood Set with Large Standard Blood ...

There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.

FDAJul 16, 2003Nationwide• Baxter Healthcare Corp. Rt

Unknown Manufacturer: Boston Scientific Scimed Monorail Express 2 Coronary Sten...

There is an Increased potential for broken struts of the stents.

FDAJul 16, 2003Nationwide

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