CELL-DYN 22 CALIBRATOR
Received Dec 1, 2006
Report 2919069-2006-00108 · MDR key 789616
Device
Generic name
Cd22 Calibrator
Manufacturer
Abbott Diagnostics Div/celldynModel number
NACatalog number
99120-01
Lot number
3098
Product problems
- Replace
- Low Test Results
Patient
NA
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE ACCOUNT STATED THAT THEY HAD USED CELL-DYN 22 CALIBRATOR LOT #3098 TO CALIBRATE THEIR CD3200 CS ANALYZER. THEY HAVE NOT HAD ANY QC ISSUES, BUT THEY WERE REQUESTING REPLACEMENT CALIBRATOR FREE OF CHARGE TO PERFORM CALIBRATION VERIFICATION. THERE WAS NO REPORT OF SUSPECT PT RESULTS.
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.
Remedial action
- Recall