Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the following methods: Albumin (ALB, ALB_c), Direct Bilirubin (DBIL_2), Total Bilirubin (TBIL_2), Calcium (CA, CA_c, CA_2, CA_2c), Cholesterol (CHOL), Creatinine (CREA, CREA_2, CRE_2c, ECRE_2), Glucose Hexakinase (GLUH), Glucose Oxidase (GLUO), Iron (IRON_2), Lithium (LITH), Magnesium (MG, MG_c), Phosphorus - inorganic (IP, IP_c), Total Protein (TP, TP_c), Triglycerides (TRIG), Urea Nitrogen (UN, UN_c), Uric Acid (UA, UA_c)

Reason: Siemens has confirmed that the DBIL_2 Assigned Calibrator Values (ACV) currently assigned to the affected lots may cause, on average, a positive proportional bias of approximately 41% on patient samples compared to the reference method for Direct Bilirubin measurement.

Code information: Device Listing # D033650 Model# SMN# 10312279 Lot Numbers: 680726, 680726A, 680726B, 680726C, 680726D

Distribution pattern: Worldwide Distribution - US (Nationwide) Internationally to Canada, Mexico, Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, Chile, Cyprus, Denmark, Egypt, Ecuador, Finland, France, Germany, Great Britain, Hong Kong, Hungary, Italy, Japan, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Poland, Portugal, Russian Fed. Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, Turkey, Vatican City and Vietnam