Company: Roche Diagnostics Corp.
Date of Enforcement Report: 9/15/04
Class: II

PRODUCT
a) Roche/Hitachi 747 – 100 clinical chemistry analyzer;
catalog number 04009223680. Recall # Z-1428-04;
b) Roche/Hitachi Modular Analytical D Module clinical
chemistry analyzer; catalog number 03739023001. Recall
# Z-1429-04;
c) Roche/Hitachi Modular Analytical D Module DAT clinical
chemistry analyzer; catalog number 04429338160. Recall #
Z-1430-04;
d) Roche/Hitachi Modular Additional D Module DAT clinical
chemistry analyzer; catalog number 04429389160. Recall #
Z-1431-04;
e) Roche/Hitachi 747 – 200 clinical chemistry analyzer;
catalog number 04009223680. Recall # Z-1432-04.

REASON
A software defect will allow the reporting out of believable, but clinically significant, erroneous results if the analyzer is in operation and a channel has been masked or not requested over a period of time.

CODE
All units.

RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by letters dated August 6, 2004.Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
392 units.

DISTRIBUTION
Nationwide.