Dade Behring, Inc. 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Dade Behring, Inc.
Lot Codes / Batch Numbers
Software versions 8.5.1 and 8.5.1SP3.
Products Sold
Software versions 8.5.1 and 8.5.1SP3.
Dade Behring, Inc. is recalling Dimension EXL Clinical Chemistry System used with software versions 8.5.1 and 8.5.1SP3. The system due to Error messages, "Wash Aspirator Failure" and "Wash station unable to recover" are not generated when one or both HM wash probes are totally occluded.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Error messages, "Wash Aspirator Failure" and "Wash station unable to recover" are not generated when one or both HM wash probes are totally occluded.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026