Company: Roche Diagnostics Corp.
Date of Enforcement Report: 1/21/04
Class: II
PRODUCT
a) Roche brand OMNI 7 clinical chemistry analyzer; catalog
numbers GD0435 and GD0435R. Recall # Z-0326-04;
b) Roche brand OMNI 8 clinical chemistry analyzer; catalog
numbers GD0455 and GD0455R. Recall # Z-0327-04;
Roche brand OMNI 9 clinical chemistry analyzer; catalog
numbers GD0475, GD0475R and GD047591.
Recall # Z-0328-04.
REASON
If the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sample volume.
CODE
All units with software version 5.61 or below.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by letter on or about December 15, 2003. FDA initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
131.
DISTRIBUTION
Nationwide.
