LIVES EBV VCA - EA IgG - Record 10158120637 - Lots 1000945440 and 1001073190. 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.

If an untreated SPR is used with the C1 (positive control) or S1 (kit standard) the customer will verify a control or calibration of the kit, not compliant, in this case there will be no result provided to the patients. If an untreated SPR is used with C2 (negative control), this negative control will give a negative result as expected, and the client will not be aware of this problem. If an untreated SPR (cone) is used with a sample, based on the fact that the signal loss may be 50%, the following situations may occur: - a sample with a theoretical positive result could give a wrong result but not a negative result and a sample with erroneous theoretical feedback could give a negative result. Applying the Risk Assessment procedure from our employer we arrive at: The severity of providing a false report is SERIOUS, and may have a negative influence on the medical diagnosis without permanent impact on the patient's health because other diagnostic information must be available. More specifically, because the biological interpretation for a diagnosis of infectious mononucleosis should be based on the results of at least 03 EBV VIDAS assays and not only the results of VIDAS EBV VCA / EA IgG. The probability of occurrence is PROBABLE, indicating that it could occur at multiple times (more often) over the lifetime of the affected lots. In general, the risk associated with the presence of untreated SPRs in both batches of VIDAS EBV VCA / EA IgG is considered to be GREATER. #### CLOSED ####