Alerta De Seguridad para Diluente / Sheath - Record nº 10055310747

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.

No medical damage or events have been reported on the CELL DYN 3200 equipment when using Diluent / Sheath CD 3200 lot number 10055310747 between February 24, 2004 and September 10, 2004. Always make sure that the background counts are in of the specifications before testing controls and patient samples. If the control results are within acceptable limits, but background counts are out of specification, DO NOT TEST SAMPLES OF PATIENTS. If contaminated reagents are suspected, this may have contaminated the Diluent / Sheath filter. Consequently, the filter must be changed before using the reagent batch. Filter torch instructions are found in the Monthly Maintenance Section of Chapter 9: Services and Maintenance. If the Diluent / Sheat CD 3200 with lot number 1795412 is in stock, discontinue using the lot listed if the platelet count is above 0.5 / ul as mentioned in the CD 3200 Operating Manual. Continued use of the said lot if the platelet count is up to 0.5K / ul. Fill in the Response Protocol for later return of the product. Abbott Laboratories will collect the material and provide a refund. Contact your Abbott representative to request a replacement. For any additional questions or concerns, contact the Abbott Customer Service Center Diagnostics Division Telephone 0800-11-9099.