Company: Tegimenta
Date of Enforcement Report: 10/17/01
Class: II

RECALL NUMBER, PRODUCT AND CODE:
Z-0008-2, COBAS Integra 400 laboratory clinical chemistry analyzer, Model
400, Catalog number 1045199.
All serial numbers of analyzers lower than 38-2606. Serial numbers of
38-2606 or higher have already been updated with software revision upgrade 4.

REASON:
If the operator fails to position the diluent on the instrument, the instrument may not detect that the reagent is missing an aspirate air instead of diluent.

MANUFACTURER:
Tegimenta, AB Switzerland,

RECALLED BY:
Roche Diagnostics Corp. Indianapolis, IN, by letter dated August 17, 2001.

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
Nationwide

QUANTITY:
161 units