Safety Alert for Enzygnost Syphilis, Record: 10345161559. Presentation: Content for: 192 determinations (2 x 96); Content for: 960 determinations (10 x 96). Lots: 42912; 43035; 43508; 43901.

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.

All wells on an affected plate have consistently shown decreased absorbance values. Since the absorbance values ​​are below the validation limit, the board may become invalid. As indicated in the package insert, the test must be repeated if Reference N is below the limit of validation. The overseas manufacturer performed the problem analysis, evaluating all the inherent risks that generated the corrective action in the field. Based on the investigation and mitigation of the risk conducted, this action was classified as low health risk, its severity being high and its probability of occurrence extremely unlikely. #### UPDATED ON 08/21/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.