Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics is recalling 1,566 units of the Atellica IM 1300 Analyzer, an automated immunoassay analyzer used to perform diagnostic tests on clinical samples. The recall affects all lots of the device distributed worldwide, including throughout the United States and in numerous countries across Europe, Asia, the Middle East, Africa, and South America. The analyzer has incompatibility issues with Test Definition Version 1.4 that could potentially cause it to generate incorrect total T3 test results.
The source document does not specify a remedy or corrective action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results
Reason for recall: Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results 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, Slov Quantity: 1,566 Lot/code info: UDI: 00630414007960 All lots
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.