Home / Recalls / Medical Devices
Siemens Healthcare Diagnostics, Inc. recalls (1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN): 11314237 (2) Atellica Data Manager softw
Recalled July 8, 2020 · FDA recall Z-2438-2020 · Siemens Healthcare Diagnostics
Hazard
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 · FDA Class II
Units
70 units
Sold at
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.
Description
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
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.
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →