Date of Enforcement Report: 10/17/01
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.
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.
Tegimenta, AB Switzerland,
Roche Diagnostics Corp. Indianapolis, IN, by letter dated August 17, 2001.
FIRM INITIATED RECALL: