Z-2172-2012Class II

EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classified as a...

Name: Z-2172-2012 EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classified as a...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2012-06-07
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-06-07 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with... on 2012-06-07. FDA classified it as Class II and gives the reason as "There is a potential for the EasyLink system to display and transmit to the Laboratory Information System networks an incorrect result following the EasyLink systems application of the configured result number format...". 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-2172-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-07
Posted: 2012-08-09
Terminated: 2014-08-26
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-Vitro diagnostics devices.
Product code: NSX
Reason for recall: There is a potential for the EasyLink system to display and transmit to the Laboratory Information System networks an incorrect result following the EasyLink systems application of the configured result number format. The problem is encountered when the result number format configured on the Sysmex CA-7000 or CA-1500 coagulation analyzer does not match the EasyLink system settings on the following
Root cause tag: software
FDA root cause: Software design
Action: The firm initiated this recall on June 7, 2012 by issuing an "Urgent Field Safety Notice" to all customers who are known to have the EasyLink system and who also own and operate Sysmex CA-1500 and CA-7000 instruments. The Notice described the problem and provided recommended actions. Customers can contact 800-441-9250 for questions.
Quantity in commerce: 237
Distribution: Worldwide distribution, including the countries of Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Italy, Netherlands, New Zealand, Slovakia, Spain, Switzerland and the United States, with nationwide distribution. Center Recall Depth is Retail.
Product codes and lots: Version 5.0 and Version 5.0 Service Pack 1 through 4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2172-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2172-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-09

Product code NSX

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