Company: Dade Behring, Inc
Date of Enforcement Report 1/21/2009
Class:ll
PRODUCT
Dimension EXL Clinical Chemistry System used with software versions 8.5.1 and 8.5.1SP3. The system is a discrete, random-access, microprocessor-controlled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities, in body fluids for in vitro diagnostic use. Recall # Z-0581-2009
REASON
Error messages, “Wash Aspirator Failure” and “Wash station unable to recover” are not generated when one or both HM wash probes are totally occluded.
RECALLING FIRM/MANUFACTURER
Dade Behring, Inc., Newark, DE, by telephone and follow-up letter dated September 8, 2008. Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
57 units
DISTRIBUTION
Nationwide
