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Showing 22401–22420 of 22623 results

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Beckman Coulter Inc: IMMAGE IGMLC Reagent Part Number: 447470

Inconsistent results are obtained depending upon the matrix or sample source (plasma versus cerebrospinal fluid).

FDAJun 6, 2003Nationwide• Beckman Coulter Inc

A.R.C. Laser Corp: A.R.C. Laser Photolysis Probe/Handpiece

Product may not have been properly sterilized.

FDAJun 6, 2003IN, NY, PA +1 more• A.R.C. Laser Corp

ABX Diagnostics Inc: ABX Diagnostices Pentra 60C+ Hematology Analyzer

Instrument fails to obtain correct patient information/results due to malfunction of the equipment's sample door.

FDAJun 4, 2003Nationwide• ABX Diagnostics Inc

Safco Dental Supply Co. Inc.: Supergrade Earloop Masks, surgical mask; 50 masks per box...

The product labeling incorrectly lists the particle filtration efficiency as exceeding 99% at 0.1 micron when it should state 95% filtration.

FDAJun 3, 2003Nationwide• Safco Dental Supply Co. Inc.

The OR Group, Inc. A Subsidiary of Hill-Rom Inc. One Post Office Square: Allen Medical Systems PAL Pro Stirrups Catalog Number: A-...

Foot Stirrups may detach from mount when user is locking system

FDAJun 2, 2003Nationwide• The OR Group, Inc. A Subsidiary of Hill-Rom Inc. One Post Office Square

Misys Healthcare Systems: Misys Laboratory System using Microbiology versions 5.2 (...

Susceptibility comments are ommited from Microbiology cumulative reports

FDAJun 2, 2003Nationwide• Misys Healthcare Systems

Cardinal Health: Temno Chiba FIne Needle Aspiration, Soft Tissue Biopsy Ne...

The product was shipped prior to being sterilized.

FDAJun 2, 2003FL, GA, MN +3 more• Cardinal Health

Stryker Instruments, Instruments Div.: Stryker Advanced Cement Mixing System Bowl and 180 Gram C...

Non-sterilized product sold as sterile.

FDAJun 1, 2003Nationwide• Stryker Instruments, Instruments Div.

Chattanooga Corp.: Triton T-700 Traction Unit,

Product contains an improper bracket for the transducer.

FDAMay 30, 2003CA, FL, IL +6 more• Chattanooga Corp.

PerkinElmer Life Sciences Inc: Neonatal Total Galactose Test Kit, Item #NG-1000, Filter ...

The device is not stable throughout its labeled expiration date.

FDAMay 30, 2003Nationwide• PerkinElmer Life Sciences Inc

Abbott Laboratories HPD/ADD: Architect Free T4 Calibrator Kit, list 7G96-01; the kit c...

The Free T4 Controls, may yield control values that are high and outside of the package insert ranges.

FDAMay 30, 2003Nationwide• Abbott Laboratories HPD/ADD

Abbott Laboratories HPD/ADD: IMx Free T4 Reagent Kit, list 2222-20, 100 test kit; Abbo...

The Free T4 Controls, may yield control values that are high and outside of the package insert ranges.

FDAMay 30, 2003Nationwide• Abbott Laboratories HPD/ADD

Abbott Laboratories HPD/ADD: Free T4 Control Pack, list 9C03-10; the kit consists of 3...

The Free T4 Controls, may yield control values that are high and outside of the package insert ranges.

FDAMay 30, 2003Nationwide• Abbott Laboratories HPD/ADD

Chattanooga Corp.: Triton MP-1 Traction Unit

Product contains an improper bracket for the transducer.

FDAMay 30, 2003Nationwide• Chattanooga Corp.

Baxter Healthcare Renal Div: Baxter System 1000 Single Patient Hemodialysis Delivery S...

The air detector may not detect air bubbles consistently at the selected limit.

FDAMay 28, 2003Nationwide• Baxter Healthcare Renal Div

Siemens Medical Solutions USA, Inc: Axiom Artis System

patient images misidentified

FDAMay 28, 2003Nationwide• Siemens Medical Solutions USA, Inc

Pioneer Surgical Technology: StayFuse PROX 03.3 MM sterile intramedullary bone screw d...

Label may bear an incorrect part number [2227-02-02] and size [03.8MM].

FDAMay 28, 2003IN• Pioneer Surgical Technology

Standard Imaging Inc.: Exradin A12 Ionization Chamber

Ionization chambers, used for checking x-ray equipment, were experiencing some drift from the tested calibration factors.

FDAMay 28, 2003Nationwide• Standard Imaging Inc.

Roche Diagnostics Corp.: MagNA Pure LC Instrument; Catalog number 2236931.

Potential for false negative patient results with software version 3.0

FDAMay 27, 2003CA, GA, IL +10 more• Roche Diagnostics Corp.

Toshiba American Med Sys Inc: Digital Fluorographic System model DFP-2000A.

Images display with wrong patient demographics.

FDAMay 27, 2003Nationwide• Toshiba American Med Sys Inc

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