(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 tes
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics is recalling CentraLink Data Management System software versions 16.0.2 and 16.0.3 due to an unexpected interface driver behavior that may cause quality control (QC) results to be assigned to an incorrect control lot number. This defect could lead to erroneous patient results being reported if a QC test fails but incorrectly appears to be passing and the error is not caught during QC review. The software has been distributed worldwide to 186 units across the United States and numerous countries including Australia, Brazil, Germany, India, Mexico, Singapore, and the United Kingdom.
The recall record does not specify a remedy for affected consumers or facilities.
Written by software from the official notice below. Not reviewed by a lawyer.
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
Reason for recall: 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 Distribution: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Australia, Bahamas, Belgium, Brazil, Chile, Colombia, Czech Republic, Egypt, Germany, Greece, Hungary, India, Italy, Kuwait, Latvia, Lithuania, Malaysia, Mexico, Oman, Peru, Poland, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom. Quantity: 186 units Lot/code info: Software versions: CentraLink Data Management System software version 16.0.2 UDI: 00630414220635 CentraLink Data Management System software version 16.0.3 UDI: 00630414237268
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.