CELL-DYN 22 CALIBRATOR

Description of Event or Problem

THE ACCOUNT STATED THAT THEY CALIBRATED THEIR CD3200 CS ANALYZER WITH CELL-DYN 22 CALIBRATOR LOT 3100 AND HAVE NOT SEEN ANY ISSUES WITH PLATELET RESULTS. THE ACCOUNT WANTED TO KNOW IF THEY STILL NEEDED TO CONFIRM THE ACCURACY OF THE PLATELET CALIBRATION. THE CUSTOMER TECHNICAL ADVOCATE (CTA) EXPLAINED TO THE ACCOUNT THAT THEY DID NOT NEED TO CONFIRM THE CALIBRATION. THE CTA CONFIRMED WITH THE ACCOUNT THAT THEY HAD DISCARDED THE LOTS INVOLVED IN THE PRODUCT RECALL. THE ACCOUNT STATED THAT THEY HAD.

Additional Manufacturer Narrative

ON-MARKET INSTABILITY FOR PLATELETS WITH CELL-DYN 22 CALIBRATOR LOTS 3098 AND 3099 IS BEING EXPERIENCED. THE CALIBRATOR COULD READ 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.