inforMED
MalfunctionIAF

WRIGHT GIEMSA STAIN

Received Feb 20, 2007 · Event occurred Jan 16, 2007

Report 3002805583-2007-00001 · MDR key 2195570

Device

Generic name

Wright Giemsa Stain

Manufacturer

Volu-sol, Inc.

Catalog number

VWG

Lot number

615

Product problems

  • Appropriate Device Problem Term/Code Not Available

Patient

Not reported

  • No Information

Narrative

Description of Event or Problem

THE STABILIZER, GLYCEROL WAS ADDED TO ENHANCE THE BOLDNESS OF COLOR AND INCREASE CLARITY. THIS ENHANCED PRODUCT CAUSED WATER ARTIFACT ON RBC'S.

Additional Manufacturer Narrative

RECEIVED THIS REPORT WITHOUT THE SECOND PAGE. PER FDA DIRECTIVE ON (B)(6) 2011, THIS REPORT WILL BE PROCESSED AS IS.