Company: Raichem
Date of enforcement report: 1/31/01
Date of recall: 12/20/00
PRODUCT:
Roche Creatinine Mira, Catalog No.3033414.
Recall #Z-071-1.
REASON:
Package insert, contained in the kit, was printed with an incorrect
reagent volume for COBAS MIRA analyzers using software Version 8735.
CODE:
Lot No. A12071, Exp. September 2002.
MANUFACTURER:
Raichem, division of Hemagen, San Diego, CA.
RECALLED BY:
Roche Diagnostics Corporation, Indianapolis, IN., by letter, on December
20, 2000. Firm initiated recall ongoing.
DISTRIBUTION:
Nationwide.
QUANTITY:
2550 pieces.
