Jan

2009

Cl Il Dimension EXL Clinical Chemistry System

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

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl Il Dimension EXL Clinical Chemistry System

Amy Sellers

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