FDA Device recall Z-2172-2012
EasyLink(TM) Informatics System, Part Number 1000034805
- FDA Device
- Class II
- terminated
- Published 2012-08-15
On 2012-08-15 the FDA classified a Class II recall of EasyLink(TM) Informatics System, Part Number 1000034805 by Siemens Healthcare Diagnostics, citing 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 o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2172-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-06-07 |
| Published | 2012-08-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
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.
Reason
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
Identifiers
| code_info | Version 5.0 and Version 5.0 Service Pack 1 through 4 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2172-2012%22
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