Date of enforcement report: 1/31/01
Date of recall: 12/20/00
Roche Creatinine Mira, Catalog No.3033414.
Package insert, contained in the kit, was printed with an incorrect
reagent volume for COBAS MIRA analyzers using software Version 8735.
Lot No. A12071, Exp. September 2002.
Raichem, division of Hemagen, San Diego, CA.
Roche Diagnostics Corporation, Indianapolis, IN., by letter, on December
20, 2000. Firm initiated recall ongoing.