(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 orderi
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics is recalling Atellica Data Manager software versions 1.0 and 1.1 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 result in the reporting of erroneous patient results if a QC test failed but appeared to be passing and the issue went undetected during QC review. The software has been distributed worldwide to 70 units across numerous countries including the United States, Argentina, Australia, Belgium, Brazil, Chile, Colombia, and many others.
The recall document does not specify a remedy or recommended actions for affected consumers.
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: 70 units Lot/code info: Software versions: Atellica¿ Data Manager software version 1.0 UDI: 00630414234946 Atellica¿ Data Manager software version 1.1 UDI: 006304142790
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.