Alerta De Seguridad para VITROS IMMUNODIAGNOSTIC REAGENT KIT FOR B hCG TOTAL II - Registered in Anvisa under the number 80145901052 - Lots 0490 and 0530 - See attached list of Distribution (http://migre.me/5L5kp).

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.

Ortho Clinical Diagnostics (OCD) has received complaints of observed results from diluted samples that were reported as <2.39 mIU / mL (IU / L) instead of No Result, which would be correct, and being accompanied by an Invalid Dilution - ID (Invalid Dilution). Action plan to be executed by the company (with schedule): - Register this notification in the database system for correct traceability of the case - Action taken on August 26, 2011 - Check which customers received the affected products and batches - Action held on August 26, 2011. - Communicate clients about what happened and guide the actions to be taken - Action started on September 9, 2011. - Obtain from the client the confirmation of receipt of the communication and actions taken. The letter signed by the client confirming receipt of the notification must be returned to the company by September 23, 2011. There are no records of notifications for this problem in Brazil, to date. Anvisa is following this action.