Recall Z-2172-2012— Siemens Healthcare Diagnostics, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2012-06-07, terminated 2014-08-26. FDA's recall record names no specific 510(k) clearance for this event. 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.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-06-07
- Terminated
- 2014-08-26
- Firm location
- Newark, DE, United States
Product description
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 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.