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Showing 89521–89540 of 92409 results

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Conmed Corporation: 1680 Invisatrace series ECG Electrodes, radiotranslucent ...

Separation of the sensing element from the body of the electrode.

FDAJul 30, 2003IN• Conmed Corporation

Conmed Corporation: 1690 Ultratrace Series ECG Electrodes, clear tape ECG ele...

Separation of the sensing element from the body of the electrode.

FDAJul 30, 2003IN• Conmed Corporation

Exactech, Inc.: Exactech Tibial Offset Bushing (sizes 1, 2, 3, 4, & 5) Ca...

The alpha and beta markings on the offset tibial bushings are in a location that would lead to the improper selection of an offset tibial tray.

FDAJul 30, 2003HI, IN, ME +2 more• Exactech, Inc.

Perkinelmer Life Sciences, Inc.: Angiotensin I [125I] Radioimmunoassay Kit, 250 Tube Catal...

Incorrect calibration standard value may result in 25% higher assay values for controls and patient samples

FDAJul 28, 2003Nationwide• Perkinelmer Life Sciences, Inc.

Ortho-Clinical Diagnostics: Vitros Chemistry * GLU (glucose) Slides * 5 cartridge...

Results of glucose measurements on sodium fluoride/potassium oxalate specimens can be negatively biased when using Vitros GLU and GLU DT slides stored in the refrigerator. GLU slides are processed by high volume chemistry systems typically used in hospital laboratories.

FDAJul 28, 2003Nationwide• Ortho-Clinical Diagnostics

American Medical Systems: Monarc Subfascial Hammock With Tensioning Suture, Product...

Insertion needles from the former version of the product were packaged with the new sling with dilator that is different than the old version and not compatible with the old needles.

FDAJul 28, 2003Nationwide• American Medical Systems

Ortho-Clinical Diagnostics: Vitros Chemistry * GLU (glucose) DT Slides *25 slides...

Results of glucose measurements on sodium fluoride/potassium oxalate specimens can be negatively biased when using Vitros GLU and GLU DT slides stored in the refrigerator.

FDAJul 28, 2003Nationwide• Ortho-Clinical Diagnostics

Datascope Collagen Products Division: VasoSeal ES, Extravascular Security Vascular Closure Devi...

Kits are missing the temporary arteriotomy locator (TAL) from the blister package.

FDAJul 28, 2003Nationwide• Datascope Collagen Products Division

Roche Diagnostics Corp.: Disetronic Dahedi insulin infusion pump; catalog # 8500019.

Lack of assurance of reliability.

FDAJul 28, 2003Nationwide• Roche Diagnostics Corp.

Wilson-Cook Medical Inc: APSOF-7-4-RB, ZIMMON PANCREATIC STENT W/RADIOPAQUE BANDS,...

The label is missing the Rx Only symbol.

FDAJul 25, 2003IL, IN• Wilson-Cook Medical Inc

Roche Diagnostics Corp.: Disetronic D-TRONplus Insulin Pump

Lack of assurance of reliability and notice to D-tron+ users to examine pump keys for punctures, not to use pumps with punctured keys near water, and to alert users to the possibility of a sticking piston rod.

FDAJul 24, 2003Nationwide• Roche Diagnostics Corp.

Misys Healthcare Systems: Calculator/ Data Processing Module for Clinical Use

Software Design Defect. Under certain conditions, results are removed.

FDAJul 24, 2003Nationwide• Misys Healthcare Systems

18-Volt Cordless Drill/Drivers (Black & Decker) – Performance Issue (2003)

The recalled 18-volt, cordless drill/drivers are orange or jade and have the words, "Black & Decker" printed on the body of the drill. The drill/drivers have the following model numbers and date codes: Model Number Date Codes Color CD1800 20011952 through 20020652 Orange PS3700 973652 through 983052 Jade PS3725 20003852 through 20013652 Jade PS3750 20002454 through 20005252 Jade The model number is printed on the nameplate on the side of the drill and the date code is printed on the bottom of the handle where the battery is inserted (remove the battery to locate date code). The recalled units were manufactured in China. No other models or date codes are affected by this recall to repair.

CPSCJul 24, 2003Nationwide

Misys Healthcare Systems: Calculator/ Data Processing Module for Clinical Use

Software Defect. Data used in the diagnosis and or treatment of a patient's illness are missing from the patient result report.

FDAJul 23, 2003Nationwide• Misys Healthcare Systems

Becton Dickinson & Company: BD Blood Glucose Test strips. BD Latitude, 100 Test Stri...

Test Strips may not be meeting specifications at the lower range of glucose values.

FDAJul 23, 2003Nationwide• Becton Dickinson & Company

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

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