Alerta De Seguridad para Trade Name: IRISpec CA / CB / CC; registration number 10033120952; risk class II; lot / series: 004-16 (distributed as follows: 1 in Ceará, 5 in Rio de Janeiro, 3 in Espírito Santo, 2 in Paraná, 1 in Santa Catarina, 1 in Minas Gerais, 34 in São Paulo, 1 Pará, 6 in Maranhão and 2 in Bahia).

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 the laboratory is using any of the listed batches: • Follow the instructions for handling and storing the quality control material in accordance with the product's current package insert (IFU) to avoid premature degradation due to the technique inadequate. Bulletin Number (IFU) 300-1223. • If the IRISpec CA control for the bilirubin parameter fails, discard the vial and use another vial of the same control that accompanies the kit. Each kit consists of 3 vials of the AC control. • If the problem persists, request product replacement by contacting the customer service area at 11 4154-8818 or lmanzan@beckman.com