Raichem Cobas Mira Class III

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.