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Siemens Healthcare Diagnostics, Inc. Recall 86970

Description: Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066001 - 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.

Siemens Healthcare Diagnostics, Inc. Recall 86970 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0862-2021
Event ID86970
Event DescriptionAtellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066001 - 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.
Product TypeDevices
DistributionWorldwide 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.
Quantity1095 units
Recall ReasonMultiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results
Device Classification20210120
Device Code InfoSoftware (SW) versions V1.23.2 (SMN 11469032) or lower
Center Classification Date20210114
Recall Initiation Date20201202
Recalling FirmSiemens Healthcare Diagnostics, Inc.
Initial Notification Letter
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