Device product
Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001
Z-1252-2022
Product summary
- Event
- Event 90153
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,566
- Official record key
device-enforcement:Z-1252-2022
Official wording
Reason: Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results
Code information: UDI: 00630414007960 All lots
Distribution pattern: 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.
Derived failure modes
-
Unknown
Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results