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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Siemens Healthcare Diagnostics, Inc.: Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Control Lot Number, and lead to the reporting of erroneous patient results if the QC failed but appeared to be passing and the issue is not detected during QC review; Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Control Lot Number, and lead to the reporting of erroneous patient results if the QC failed but appeared to

Agency Publication Date: June 26, 2020
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Affected Products

Product: (1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management System software version 16.0.3 Siemens Material Number (SMN): 11314337 Product Usage: are clinical laboratory information modules which consolidate test orders and test results, provide test ordering and priority routing information to automation, apply rules to test orders and auto-verification rules for test results, and provide integrated management of quality

Software versions: CentraLink Data Management System software version 16.0.2 UDI: 00630414220635 CentraLink Data Management System software version 16.0.3 UDI: 00630414237268

Product: (1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN): 11314237 (2) Atellica Data Manager software version 1.1 Siemens Material Number (SMN): 11316888 Product Usage: are clinical laboratory information modules which consolidate test orders and test results, provide test ordering and priority routing information to automation, apply rules to test orders and auto-verification rules for test results, and provide integrated management of quality control of test system.

Software versions: Atellica¿ Data Manager software version 1.0 UDI: 00630414234946 Atellica¿ Data Manager software version 1.1 UDI: 006304142790

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85737
Status: Resolved
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Manufactured In: United States
Units Affected: 2 products (186 units; 70 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.