CELL-DYN 22 CALIBRATOR
Received Dec 4, 2006 · Event occurred Sep 18, 2006
Report 2919069-2006-00118 · MDR key 793883
Device
Generic name
Cd22 Calibrator
Manufacturer
Abbott Diagnostics Division/celldynModel number
NACatalog number
99120-01
Lot number
UNK
Product problems
- Other (for use when an appropriate device code cannot be identified)
- Unknown (for use when the device problem is not known)
Patient
NA
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
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. A RECALL WAS ISSUED AND REPORTED UNDER 21 CFR 806 TO THE FDA DISTRICT OFFICE ON 09/26/2006. ABBOTT HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS RELATED TO THE AFFECTED LOTS OF CELL-DYN 22 CALIBRATORS.
Additional Manufacturer Narrative
INVESTIGATION TO DETERMINE THE CAUSE OF THE STABILITY ISSUE IS ONGOING. THIS IS A FINAL REPORT.
Remedial action
- Recall