FDA Device recall Z-2242-2012
EasyLink Informatic System is included with the Dimension Vista System
- FDA Device
- Class II
- terminated
- Published 2012-08-29
On 2012-08-29 the FDA classified a Class II recall of EasyLink Informatic System is included with the Dimension Vista System by Siemens Healthcare Diagnostics, citing when using the EasyLink Quality Control Package the system may not perform as intended for Multi-Rule QC violations [e.g., 2(2S), 4(1s) and 10x], unless configured using the instr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2242-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-29 |
| Published | 2012-08-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic device intended tot duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. 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 and may be used with other Siemens analyzers as a communications and connectivity workstation for integration with laboratory information system (LIS) networks.
Reason
When using the EasyLink Quality Control Package the system may not perform as intended for Multi-Rule QC violations [e.g., 2(2S), 4(1s) and 10x], unless configured using the instructions send with the Urgent Field Safety Notice. When this situation occurs, QC status may not be flagged appropriately. If auto-verification rules are defined to hold patient results when QC status is out, the patient
Identifiers
| code_info | Part Number: 1000034805, 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-2242-2012%22
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