Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens Siemens Material Number (SMN): 11066000
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics, Inc. is recalling the Atellica IM 1600 Analyzer, an automated immunoassay analyzer used to perform diagnostic tests on clinical specimens. The recall affects 2,321 units distributed worldwide, including across the United States and numerous international countries. The reason for the recall is that certain lots are incompatible with Test Definition (TDef) Version 1.4, which could potentially cause the analyzer to generate erroneous total T3 (thyroid hormone) results.
The affected lots are identified by UDI 00630414002026, and the product is referenced by Siemens Material Number 110. The source document does not specify what actions affected consumers or healthcare facilities should take in response to this recall.
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: 2,321 Lot/code info: UDI: 00630414002026 All lots
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.