Alerta De Seguridad para CELL-DYN Emerald Cleaner / CELL-DYN Emerald Cleaner Registration Number ANVISA: 80146501650 ### Hazard Class: I (PRODUCTS OF LOW RISK TO INDIVIDUAL AND LOW RISK TO PUBLIC HEALTH, SUBJECT TO REGISTRATION) ### Lot : 7044

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.

Recommendations to Users and Patients: If you HAVE an alternative lot of Emerald Cleaner available in stock (except 6853, 6901, 6953, 6991, 7024 or 7027), immediately discontinue use of impacted lots of Emerald Cleaner. 1. Start using the alternative lot of Emerald Cleaner. 2. Perform the Decontamination Procedure in accordance with the CELL-DYN Emerald Operations Manual (9140859 version H), pages 9-16, steps 1 -3. (See Appendix 1.) This will take 15 to 30 minutes. 3. Check QC and follow any additional laboratory procedures. Return the remaining stock of the impacted batches of Emerald Cleaner according to your laboratory procedures. If you do not have an alternative batch available and you are not observing QC outside the low range for RBC and PLT parameters, immediately request a replacement lot from Emerald Cleaner. Make sure you meet your internal QC requirements. You can continue to use the batch until the replenishment arrives. After you receive the replacement batch, follow steps 1-3: 1. Begin using the alternative batch of Emerald Cleaner. 2. Perform the Decontamination Procedure in accordance with the CELL-DYN Emerald Operations Manual (9140859 version H), pages 9-16, steps 1-3. (See Appendix 1.) This will take 15 to 30 minutes. 3. Check QC and follow any additional laboratory procedures. Please return the remaining stock from lots 7044, 7082, 7110 or 7119 according to your laboratory procedures. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link