CLINICAL CHEMISTRY PHOSPHORUS

Description of Event or Problem

THE CLINICAL CHEMISTRY PHOSPHORUS REAGENT, LIST NUMBER 7D71-21 HAS DEMONSTRATED IMPRECISION, PRIMARILY IN THE FORM OF RESULTS WITH LESS THAN FLAGS AND IN ERROR CODE 3106/3103 (UNABLE TO PROCESS TEST, LIQUID CONTACT BROKEN DURING ASPIRATION OF REAGENT 2 PIPETTOR). ADDITIONALLY, THERE IS A POTENTIAL FOR FALSELY DEPRESSED PATIENT VALUES TO BE GENERATED. THE INVESTIGATION HAS REVEALED THE CAUSE OF THIS ISSUE IS RELATED TO THE INSUFFICIENT ASPIRATION OF THE R2 REAGENT. A PRODUCT RECALL WAS ISSUED AND REPORTED TO THE FDA, (B)(6) DISTRICT ON (B)(6) 2010. THERE HAVE BEEN TWO EVENTS OF IMPACT TO PATIENT MANAGEMENT DUE TO PATIENT RESULTS OF <0.2 MG/DL WITH NO SERIOUS OUTCOME REPORTED.

Additional Manufacturer Narrative

(B)(4). ADDITIONAL LOTS OF PHOSPHORUS, LIST NUMBER 7D71-21: 78059HW00, EXP 4/15/10; 81040HW00, EXP 7/15/10; AND 8509HW00, EXP 12/15/10. EVAL: THE INVESTIGATION HAS REVEALED THE CAUSE OF THIS ISSUE IS RELATED TO THE INSUFFICIENT ASPIRATION OF THE R2 REAGENT. IN RESPONSE TO THIS ISSUE A PRODUCT RECALL WAS INITIATED. ALL CURRENT CUSTOMERS WHO HAVE RECEIVED ANY OF THE FOUR LOTS OF CLINICAL CHEMISTRY PHOSPHORUS, LIST NUMBER 7D71-21 AND HAVE AN ARCHITECT C8000, ARCHITECT C16000 OR AEROSET ANALYZER WERE INSTRUCTED TO DISCONTINUE USE AND DESTROY ANY REMAINING INVENTORY. REPLACEMENT KITS (7D71-31 OR 7D71-22) WERE MADE AVAILABLE TO REPLACE 7D71-21. PRODUCT LABELING ADEQUATELY ADDRESSED THE CAUSES AND CORRECTIONS TO ERROR CODE 3103 AND 3106, UNABLE TO PROCESS TEST, LIQUID CONTACT BROKEN DURING ASPIRATION FOR THE REAGENT 2 PIPETTOR. ADDITIONALLY, WHEN VALUES LESS THAN THE LINEARITY OR LIMIT OF DETECTION ARE PRODUCED, THE SYSTEM GENERATES A LESS THAN FLAG ( < ) TO INDICATE TO THE OPERATOR THAT THE RESULT IS OUTSIDE THE DYNAMIC OR LINEAR RANGE FOR THE ASSAY AND SHOULD BE REVIEWED.