Company: Nova Biomedical Corporation.,
Date of Enforcement Report:1/27/2006
Class:Ill
PRODUCT
a) Star Profile Critical Care (CCX)
Analyzer Catalog Number: 35942,
Recall # Z-0576-06;
b) Star Profile Critical Care PLUS (CCX)
Analyzer Catalog Number: 37413,
Recall # Z-0577-06;
c) CCX Operating Software, Version 4.08,
Recall # Z-0578-06
REASON
Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs.
CODE
a) and b) All serial numbers;
c) Version 4.08
RECALLING FIRM/MANUFACTURER
Nova Biomedical Corporation, Waltham, MA, by letter on January 27, 2006, firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
906 units
DISTRIBUTION
Nationwide and Internationally