U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Error in the ca12 calibration value for pco2 recorded in the cal pack barcode for lot 17323. this error will result in falsely elevated pco2 results at the high end of the measuring range.
조치
A total of four (4) distributors were sent the recall package (Field Action Notice) by email on 6-29-07. The distributors were provided background information and specific instruction that all Cal packs from lot 17323 should be removed from customer sites and destroyed. The Recall package included a Management Cover for Field Action Notes, a Customer Letter and the Field Action Notice #915-261.
All communications regarding field actions associated with this recall were distributed using the Radiometer Field Action Note (FAN) system.