CELL-DYN 22 WB CONTROL

Description of Event or Problem

VALUE ASSIGNMENT ISSUES WITH AT LEAST 3 CONSECUTIVE LOTS OF CELL-DYN 22 QUALITY CONTROL MATERIAL PRODUCED BY ABBOTT LABORATORIES AND BEING USED FOR CELLDYN 3200 HEMATOLOGY ANALYZERS. CONTROLS RUN OUTSIDE MANUFACTURER RANGES FROM THE OUTSET DESPITE THE ANALYZER BEING IN CONTROL FROM THE PREVIOUS LOT AND BEING CALIBRATED ONLY A FEW MONTHS PREVIOUSLY. CALL CENTER STAFF ACKNOWLEDGE ISSUES, BUT NO FOLLOW-UP LETTERS ISSUED BY ABBOTT. CALIBRATION IS NOW RECOMMENDED BY CALL CENTER STAFF PER LOT OF QUALITY CONTROL MATERIAL DESPITE INSTRUMENT MANUAL STATING BIANNUAL IS ALL THAT IS NEEDED. NO EXPLANTATION GIVEN BY ABBOTT FOR POOR PRODUCT PERFORMANCE. POTENTIAL FOR ADVERSE EFFECT ON PATIENT DATA ESPECIALLY IF SEQUENTIAL RESULTS ARE MONITORED AS CALIBRATION MUST BE ADJUSTED APPROX EVERY 2 MONTHS OR WITH ISSUE OF NEW CONTROL LOT. CONCERN THAT NO OFFICIAL INFORMATION HAS BEEN PUBLISHED BY ABBOTT RECOGNIZING THE ISSUE AND PROVIDING STANDARDIZED RESOLUTION FOR CUSTOMERS, AND THE PATIENTS THEIR LABORATORY CUSTOMERS SERVE. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: CONTROL OF HEMATOLOGY LAB TESTING RESULTS.