D-dimer IMMULITE / IMMULITE 1000 Technical Name: D-DÍMERO Registration Number ANVISA: 10345161779 Hazard Class: III Affected Model: 100 test kit Serial Affected: 346 의 안전성 경고

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Siemens has isolated the cause of the negative bias from the adjusters used in kit 346 lot. Siemens recommends the transition to batches of kit 347 and above to IMMULITE / IMMULITE 1000 D-dimer, which utilize batches of unaffected adjusters.