Siemens EasyLink Informatic System Recalled for Quality Control Defect
Siemens Healthcare Diagnostics is recalling 637 EasyLink Informatic Systems because they may fail to flag quality control violations, potentially affecting patient result verification.
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 defect that may lead to improper handling of patient results due to unflagged quality control violations, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 637 units of the EasyLink Informatic System, which is included with the Dimension Vista System. The EasyLink is a data calculator and processing module used for in vitro diagnostic devices and laboratory information system integration.
The recall was initiated because the system may not perform as intended for Multi-Rule Quality Control (QC) violations, such as 2(2S), 4(1s), and 10x. When this occurs, the QC status may not be flagged appropriately. If auto-verification rules are defined to hold patient results when QC status is out, the failure to flag these violations could impact the handling of patient results.
The affected units are Part Number 1000034805, Version 5.0 and Version 5.0 Service Pack 1 through 4. The products were distributed nationwide in the United States and in numerous countries including Canada, France, Germany, and Japan. Users should configure the system using the instructions provided in the Urgent Field Safety Notice to ensure proper performance.
The recalled product
- 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
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 637
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 (2)
- Part Number: 1000034805
- Version 5.0 and Version 5.0 Service Pack 1 through 4
Distribution
Distributed nationwide across the United States.
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