Z-0121-2011

EasyLink Informatics Systems QCFIRST Custom Rule The EasyLink Informatics System is classified as a data...

Name: Z-0121-2011 EasyLink Informatics Systems QCFIRST Custom Rule The EasyLink Informatics System is classified as a data...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2010-07-23
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-07-23 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of EasyLink Informatics Systems QCFIRST Custom Rule The EasyLink Informatics System is classified as a data calculator and processing module for use with In-vitro... on 2010-07-23. The reason FDA records is "the EasyLink QCFIRST custom rule does not operate as intended". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0121-2011
Status: Terminated
Initiated: 2010-07-23
Posted: 2010-10-21
Terminated: 2013-03-19
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: EasyLink Informatics Systems QCFIRST Custom Rule The EasyLink Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostic devices. The EasyLink is included with the Dimension Vista System (K051087), and may be used with other Siemens analyzers, as a communications and connectivity workstation for integration with laboratory information system (LIS) networks.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: the EasyLink QCFIRST custom rule does not operate as intended.
FDA root cause: Other
Action: Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice dated July 2010 to all customers that have the EasyLink QCFIRST custom rule installed. This Urgent Field Safety Notice included information on the problem and confirmed that a Siemens representative would contact them to facilitate the removal of the rule from the EasyLink System. For questions contact the Siemens Healthcare Diagnostics Technical Solution Center at 1-800-441-9250.
Quantity in commerce: 82
Distribution: Worldwide Distribution - USA including AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MO, MS, NC, NH, NJ, NM, NY, OH, OR, PA, TX, VA, WA, WI, and WY and the country of Canada.
Product codes and lots: Part # 1000034805

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