Z-0373-05

StreamLab Analytical Workcell. General Purpose Laboratory Device

Name: Z-0373-05 StreamLab Analytical Workcell. General Purpose Laboratory Device
Creator: Dade Behring , Inc.
Published: 2004-11-12
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2004-11-12 / Terminated / root cause: software

FDA source

Dade Behring , Inc. began a recall of StreamLab Analytical Workcell. General Purpose Laboratory Device on 2004-11-12. The reason FDA records is "Software can sample the incorrect specimen from the StreamLAB to the Dimension RxL or RxL Max Systems". 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-0373-05
Status: Terminated
Initiated: 2004-11-12
Posted: 2004-12-28
Terminated: 2005-03-28
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: StreamLab Analytical Workcell. General Purpose Laboratory Device.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Software can sample the incorrect specimen from the StreamLAB to the Dimension RxL or RxL Max Systems.
Root cause tag: software
FDA root cause: Other
Action: The recalling firm issued letters dated 11/12/04 to their customers informing them of the problem. The letter also states that a sales representative will contact them to make arrangements for an upgrade.
Quantity in commerce: 15 units
Distribution: The product was shipped to hospitals in IL, MD, NJ, OH, and VA. The product was also shipped to Italy, Spain, and Portugal.
Product codes and lots: Software version 3.5

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)