ALINITY I ACTIVE B12 (HOLOTRANSCOBALAMIN) REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I ACTIVE B12 RESULT GENERATED ON AN ALINITY I PROCESSING MODULE FOR ONE PATIENT SAMPLE. SID (B)(6) RESULT ON LOT 12569UP00 = 29.7 PMOL/L, RESULT ON OTHER LOT = 18.1 PMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. CONTINUED INFORMATION FOR SECTION E1 PHONE NUMBER: (B)(6).