(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.
Recall
- Recall Number
- Z-2438-2020
- Event Number
- 85737
- Firm
- Siemens Healthcare Diagnostics, Inc.
- FEI Number
- 2432235
- Product Code
- N/A
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- May 15, 2020
- Terminated
- May 18, 2021
- Address
- 511 Benedict Ave, Tarrytown, NY, 10591-5005
Description
(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.
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
Siemens issued an Urgent Medical device Correction (UMDC ISW-20-01.A.US) and Urgent Field Safety Notification (UFSN ISW-20-01.A.OUS) to affected Customers via overnight mail on 5/15/20. The UMDC ISW 20-01.A.US and UFSN ISW-20-01. Letter states reason for recall, health risk and action to take: Manually Review QC results in CentraLink/Atellica DM daily; Review this letter with your Medical Director. If your laboratory may be affected by this issue based on the conditions listed above, you may consider the following steps to avoid this issue from occurring until Siemens updates your driver: Do not process QC while the interface communication is interrupted Use the Control lot number as the Control ID. Customers were requested to respond via the attached effectiveness check form to indicate receipt and understanding of the letter. Siemens will contact all affected customers to schedule a date to update the interface driver to version 1.5.1, which prevents the issue fromoccurring.
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.
70 units