Home / Recalls / Siemens Healthcare Diagnostics, Inc. / Z-0863-2021

Z-0863-2021 Class II Terminated

Recalled by Siemens Healthcare Diagnostics, Inc. — Tarrytown, NY

Recall Details

Product Type
Devices
Report Date
January 20, 2021
Initiation Date
December 2, 2020
Termination Date
June 6, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1588 units

Product Description

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.

Reason for Recall

Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results

Distribution Pattern

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.

Code Information

Software (SW) versions V1.23.2 (SMN 11469032) or lower

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