CELL - DYN 26 CONTROL. Nº LIST 1H71-01 - Lot No: CD013 의 안전성 경고

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.

- Use the revised protocol (No. 9155136E) for product CELL DYN Control 26, lot CD013 and enter the correct value for HCT (all levels), MCH (low level) and MCHC (low level) in the System Quality Control file CELL-DYN 3200 following the instructions in the CELL DYN 3200 Operator's Manual, section 5. - Disregard the protocol prior to no. 9155136E of the CELL DYN product Control 26 above for lot CD013 - If you have established your own measures and ranges for lot CD013 , and inserted them into the Quality Control files of the Cell Dyn 3200 instrument, disregard the protocol of the CELL DYN Control 26 product. For more information, contact the Customer Service Center at 0800-119099.