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Showing 22361–22380 of 22623 results

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Beckman Coulter Inc: Synchron LX Systems Primary Tube Sample Template (a piec...

Dead volume on sight gauge for the Synchron LX 20 and LX 20 Pro Systems not stated, which may result in instrument error.

FDAJun 19, 2003Nationwide• Beckman Coulter Inc

Bayer HealthCare LLC, Diagnostics Div: Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C...

Analyzer will produce erroneous results due to missing grounding strap.

FDAJun 19, 2003Nationwide• Bayer HealthCare LLC, Diagnostics Div

Beckman Coulter Inc: Access Immunoassay System Technical Update 03.1, Part num...

Defective software media distributed with upgrade software may cause installation failure and systems lock.

FDAJun 18, 2003Nationwide• Beckman Coulter Inc

LMA North America Inc: LMA- Unique Laryngeal Mask Airway Size 4, Catalog No. 1...

Sterility cannot be assured

FDAJun 18, 2003Nationwide• LMA North America Inc

Portex Inc.: Lo-Profile Fenestrated Tracheostomy Tube, Cuffed and Fene...

Mislabeled:Tracheostomy tube was not fenestrated as specified on the label

FDAJun 18, 2003CA, GA, MO• Portex Inc.

Meridian Bioscience Inc: Premier CMV IgG Elisa Kits, EIA diagnostic test kits, 96 ...

The Low Positive Standard kit component is losing potency that may result in false positive test results.

FDAJun 18, 2003CA, IN, KY +3 more• Meridian Bioscience Inc

Biomet, Inc.: Stanmore modular hip system; Stanmore CoCr femoral size 1...

The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.

FDAJun 18, 2003Nationwide• Biomet, Inc.

Exactech, Inc.: Product is packed in plastic Tyvek packaging and is label...

Instrument is excessively flexible making it unusable by the surgeon.

FDAJun 17, 2003GA, IN, LA +2 more• Exactech, Inc.

Unknown Manufacturer: EBI VueCath Endoscopic Spinal System

Non sterile device is labeled sterile.

FDAJun 17, 2003Nationwide

Sanarus Medical Inc: Sanarus Visica Treatment System (disposable), Model/Produ...

Corrosion in stainless steel device shaft that allows Argon gas to escape from device during a cryoablation procedure.

FDAJun 16, 2003Nationwide• Sanarus Medical Inc

Mitek Worldwide: Profile 7 x 25 mm Cannulated Interference Screw Round Hea...

Mislabeled -Incorrect Screw Size. The unit labeled 7x 25 mm screw may be a 8 x2 0 mm; and the unit labeled 8 x20 mm may be a 7 X 25mm

FDAJun 16, 2003CA, FL, MO +5 more• Mitek Worldwide

Misys Healthcare Systems: Misys Laboratory System versions 5.3 up to 5.3.2 with Ana...

Software anomaly allows patient reports to contain incomplete data used for diagnosis or treatment.

FDAJun 16, 2003Nationwide• Misys Healthcare Systems

Mitek Worldwide: Profile 8 x 20 mm Cannulated Interference Screw Round Hea...

Mislabeled -Incorrect Screw Size. The unit labeled 7x 25 mm screw may be a 8 x2 0 mm; and the unit labeled 8 x20mm may be a 7 X 25mm

FDAJun 16, 2003CA, FL, MO +5 more• Mitek Worldwide

Ballard Medical Products: Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Ca...

Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.

FDAJun 13, 2003Nationwide• Ballard Medical Products

Ohmeda Medical, A division of Datex-Ohmeda, Inc.: Servo Controlled Oxygen System for Ohmeda''s Medical Gira...

Firm's received complaints of medical device malfunction affecting instrument's calibration and alarm systems.

FDAJun 13, 2003Nationwide• Ohmeda Medical, A division of Datex-Ohmeda, Inc.

DPC Cirrus: Immulite 2000. Immunoassay system. Software version 2.6...

Version 2.6 software was released however it will not properly handle adjustment slopes.

FDAJun 13, 2003IN• DPC Cirrus

Zeus Scientific Inc: Cytomegalovirus (CMV) IgG ELISA Test System, In-Vitro Dia...

The Calibrator included within the kit may be losing reactivity.

FDAJun 12, 2003Nationwide• Zeus Scientific Inc

Abbott Laboratories HPD/ADD: AxSYM AFP Reagent Pack, list 7A48-22 (100 test kit), 7A48...

AFP results obtained when using the 1:101 automated dilution protocol showed an overestimation of AFP of up to 30.5%

FDAJun 12, 2003Nationwide• Abbott Laboratories HPD/ADD

Beckman Coulter Inc: Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenob...

Product was found to produce higher recoveries by about 7-12% compared to other lots.

FDAJun 11, 2003Nationwide• Beckman Coulter Inc

Rx Textiles Inc: PHS, Tubular Stockinette Cotton, 6''x 48'' , 8''x 72'', 4...

Product may not be sterile.

FDAJun 11, 2003CA, IN, NV• Rx Textiles Inc

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