ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA-19-9XR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods.

Reason: The six ARCHITECT CA 19-9XR reagent lots are demonstrating a shift up in patient results. The Abbott Controls however do not detect the upward shift and will test within range.

Code information: lot 08849M500 exp. 10/13/2012; lot 08851M500 exp. 10/13/2012; lot 08852M500 exp. 11/30/2012; lot 08853M500 exp. 11/30/2012; lot 10040M500 exp. 11/30/2012; and lot 10122M500 exp. 11/30/2012

Distribution pattern: Worldwide Distribution - US (nationwide) the states of: Alabama, Arkansas, Arizona, California, Florida, Iowa, Indiana, Louisiana, Michigan, Minnesota, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Texas, Virginia, Washington, including Puerto Rico, and the countries of Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Barbados, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Gaza & Jericho, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kyrgyzstan, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Mexico, Montenegro, Morocco, Netherlands, New Zealand, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Republic of Yemen, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Togo, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela and Vietnam.