Z-0581-2009

Dimension EXL Clinical Chemistry System used with software versions 8.5.1 and 8.5.1SP3. The system is a...

Name: Z-0581-2009 Dimension EXL Clinical Chemistry System used with software versions 8.5.1 and 8.5.1SP3. The system is a...
Creator: Dade Behring, Inc.
Published: 2008-09-30
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2008-09-30 / Terminated / root cause: software

FDA source

Dade Behring, Inc. began a recall of 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... on 2008-09-30. The reason FDA records is "Error messages, "Wash Aspirator Failure" and "Wash station unable to recover" are not generated when one or both HM wash probes are totally occluded". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0581-2009
Status: Terminated
Initiated: 2008-09-30
Posted: 2009-01-13
Terminated: 2009-05-05
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 57 units
Distribution: 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.
Product codes and lots: Software versions 8.5.1 and 8.5.1SP3.

Product code JJE

K073604Class IIDimension Exl with Lm Clinical Chemistry System, Dimension Ft4l Flex Reagent Cartridge, and Loci Thyroid Calibrator, ModDade Behring, Inc. / cleared 2008-03-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)