TPHA 100 - Anvisa Registry No. 10158120530 - Affected lots: 1109105154, 1202105882 and 1203106010. 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.

Tests performed showed no difference in interpretation (positive or negative) with leaking bottles, and investigations estimate that a leak can be easily seen by the customer, so he will not use the impacted bottle and the kit. In addition, TPHA 100 contains both positive and negative controls that allow you to validate the test or not. In the case of a highly compromised concentration of solution R1, the positive control serum (R3) will not be the same as that on the vial label (+ -1 dilution), and then the test will not be validated. As mentioned in the package leaflet, the results depend on the individual characteristics of the patient's immune response and should be interpreted taking into account clinical and epidemiological data. Reagent R1 is composed of a suspension of chicken erythrocytes sensitized with soluble components of treponema pallidum with 1 g / l sodium azide. As mentioned in the package leaflet, it is recommended that these products be treated as potentially infectious and handled observing the usual safety precautions (do not ingest or inhale). If these recommendations are followed, there is no specific risk of handling a vial of R1 that has leaked. Anvisa follows this action. #### CLOSURE - File 0696150 / 13-9.