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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0862-2021 |
| Event ID | 86970 |
| Event 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. |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | 1095 units |
| Recall Reason | Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results |
| Device Classification | 20210120 |
| Device Code Info | Software (SW) versions V1.23.2 (SMN 11469032) or lower |
| Center Classification Date | 20210114 |
| Recall Initiation Date | 20201202 |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc. |
| Initial Notification | Letter |
| Similar To |