Siemens EasyLink Informatics System Recalled for Incorrect Diagnostic Results
Siemens Healthcare Diagnostics is recalling 237 EasyLink Informatics Systems because they may display and transmit incorrect results to Laboratory Information Systems when used with specific coagulation analyzers.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that may transmit incorrect diagnostic results, which poses a risk of harm to patients through misdiagnosis or treatment errors, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 237 units of the EasyLink(TM) Informatics System, Part Number 1000034805. This device is a data calculator and processing module used with In-Vitro diagnostics devices. The recall covers Version 5.0 and Version 5.0 Service Pack 1 through 4.
The recall is due to a potential for the EasyLink system to display and transmit incorrect results to Laboratory Information System networks. This issue occurs when the result number format configured on the Sysmex CA-7000 or CA-1500 coagulation analyzer does not match the EasyLink system settings.
The affected units were distributed worldwide, including in Australia, Austria, Belgium, Canada, the Czech Republic, France, Germany, Italy, the Netherlands, New Zealand, Slovakia, Spain, Switzerland, and the United States. The recall depth is retail. Users should contact Siemens Healthcare Diagnostics for further instructions on how to resolve the configuration mismatch.
The recalled product
- 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.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 237
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Version 5.0 and Version 5.0 Service Pack 1 through 4
Distribution
Distributed nationwide across the United States.
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