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.
FDA Recall Z-0581-2009 · Posted 2009-01-13
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Recalling FirmDade Behring, Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2008-09-30
Date Terminated2009-05-05
Product Quantity57 units
Reason for Recall
Error messages, "Wash Aspirator Failure" and "Wash station unable to recover" are not generated when one or both HM wash probes are totally occluded.
Firm Action
The recalling firm notified consignees by telephone to inform them of the problem. A follow-up letter, "Urgent Field Safety Notice" dated 9/30/08 was issued with information describing the problem, the possible impact of an occluded wash probe on assay results, and emphasizing regular performance of routine wash probe maintenance as detailed in the operator guide to prevent wash probe occlusion. For questions, please contact the Siemens Technical Solution Center at 800-441-9250.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution including states of AR, CA, CO, IA, ID, IL, IN, LA, MD, MI, MO, MS, NC, NE, OH, OK, PA, SD, TN, TX, VA, and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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