CELL-DYN 22 CALIBRATOR

Description of Event or Problem

THE ACCOUNT STATED THAT THEY HAD CALIBRATED THEIR CD3200 SL ANALYZER WITH CELL-DYN 22 CALIBRATOR LOT #'S 3099 AND 3100. THE ACCOUNT HAS BEEN GETTING DELTA CHECKS ON SOME PTS. DUE TO THE RECALL LETTER THAT THEY RECEIVED THEY ARE CONCERNED. THE CUSTOMER TECHNICAL ADVOCATE (CTA) SUGGESTED THAT THE ACCOUNT CHECK THE PT PLATELET VALUES WITH AN OUTSIDE LABORATORY. THE ACCOUNT DECLINED. THE ACCOUNT STATED THAT THEY HAVE NOT HAD ANY ISSUES WITH QC.

Additional Manufacturer Narrative

ON-MARKET INSTABILITY FOR PLATELETS WITH CELL-DYN 22 CALIBRATOR LOTS 3098 AND 3099 IS BEING EXPERIENCED. THE CALIBRATOR COULD READK HIGHER BY AT LEAST 10% ON THE CELL-DYN RUBY AND AS MUCH AS 22% ON THE CELL-DYN 3200. IF THIS CALIBRATOR IS USED AND THE CALIBRATION FACTOR ON THE INSTRUMENT IS ADJUSTED, A NEGATIVE PLATELET SAMPLE BIAS COULD RESULT. AS A PRECAUTION, LOT 3100 WAS ALSO REMOVED FROM USE. INVESTIGATION INTO THE CAUSE OF THIS INSTABILITY IS IN PROGRESS. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.