Home / Recalls / Medical Devices
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11
Recalled January 20, 2021 · FDA recall Z-0863-2021 · Siemens Healthcare Diagnostics
Hazard
Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results · FDA Class II
Units
1588 units
Sold at
Worldwide distribution - US Nationwide distribution and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, P.R. China, Pakistan, Peru, Poland, Portugal, Qatar, Republic Korea, Romania, Russian Fed. Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E. Ukraine, United Kingdom, Uruguay, Vatika City, Vietnam.
Description
Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results
Product
Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066000 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →