Siemens Healthcare Diagnostics, Inc. Recall 90153
Description: Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001
Siemens Healthcare Diagnostics, Inc. Recall 90153 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1252-2022 |
| Event ID | 90153 |
| Event Description | Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Albania, Argentina, Austria, Bahamas, Bangladesh, Belgium, Brazil, Chile, China, Columbia, Croatia, Czech¿Republic, Denmark, Ecuador, Egypt, France, Germany, Greece, India, Israel, Italy, Japan, Korea, Latvia, Malaysia, Mexico, Netherlands, Paraguay, Peru, Philippines, Portugal, Romania, Russian¿Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., United Kingdom, Vietnam. |
| Quantity | 1,566 |
| Recall Reason | Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results |
| Device Classification | 20220615 |
| Device Code Info | UDI: 00630414007960 All lots |
| Center Classification Date | 20220609 |
| Recall Initiation Date | 20220413 |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc. |
| Initial Notification | Letter |
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