Trade Name: Hemoglobin Analyzer System; ANVISA registration number: 80020690313; Risk class: II; Affected model (s): D-10; Lot (s) / Serial numbers pertaining to the sample carrier (accessory of the D-10 Hemoglobin Analyzer System) used in conjunction with the hemoglobin analyzer: DR3D787812, DR3F803105, DR3F803104, DR4D878307, DR4F888608, DR4D878308, DR4D878309, DR4D878310, DR4F888602, DR4F888601, DR4D878312, DR3G803201, DR4F888603, DR4D878311, DR3A763707, DR3A763705. 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.

The company should clarify that the serial numbers reported refer to the Rack Loader, a sample loader, which is an optional accessory for routine laboratories. The risk is directly related to the joint use of the in-vitro diagnostic equipment "D-10 Hemoglobin Analyzer System" and the sample loader, there being no risk of using the equipment without this accessory, therefore, this field action involves the serial numbers of the sample loaders distributed in Brazil. Thus, we reiterate that only users of the "D-10 Hemoglobin Analyzer System" equipment that have the Rack Loader accessory, sample loader, are subject to the risk.//// There is a possibility of incorrect treatment for patients if the laboratory does not review the results before the release ./// The company will release a new statement once it has a definitive solution to the problem.