Z-1174-2007

EasyLink Informatics System, software version 3.0, Part Number 1000034941, DADE BEHRING INC., Newark, DE

Name: Z-1174-2007 EasyLink Informatics System, software version 3.0, Part Number 1000034941, DADE BEHRING INC., Newark, DE
Creator: Dade Behring, Inc.
Published: 2007-07-03
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2007-07-03 / Terminated

FDA source

Dade Behring, Inc. began a recall of EasyLink Informatics System, software version 3.0, Part Number 1000034941, DADE BEHRING INC., Newark, DE on 2007-07-03. The reason FDA records is "Sample ID and Patient results could be associated with the wrong patient". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1174-2007
Status: Terminated
Initiated: 2007-07-03
Posted: 2007-08-22
Terminated: 2007-11-07
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: EasyLink Informatics System, software version 3.0, Part Number 1000034941, DADE BEHRING INC., Newark, DE.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Sample ID and Patient results could be associated with the wrong patient
FDA root cause: Other
Action: The recalling firm issued a Field Corrective Action letter dated 7/3/07 to inform their customers of the problem and that a software patch would be sent for them to download. The recalling firm plans to telephone the customers after the patch has been released to verify that it has been installed.
Quantity in commerce: 72 units
Distribution: Worldwide: USA including states of AZ, CA, FL, IL, MA. MI, MO, NC, OH, PA, TX, and WV. The product was also shipped to other Dade facilities in MO, DE, IL, CT, and Belgium.
Product codes and lots: Part number 1000034941

Product code JJE

K051087Class IDimension Vista Integrated SystemDade Behring, Inc. / cleared 2005-07-11

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)