Abbott laboratories has identified an issue with the architect hemoglobin a1c calibrator lot 54582uq02, list#04p52-01.It was noted that the calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot and although this lot may generate an active calibration curve, a shift to qc and patient results may occur.It was further observed that between the hba1c concentration range of 5.33% to 6.87%, there is no impact to assay performance, however, outside of this range a bias of greater than 3% may be seen with patient results.There have been no reported injuries or impact to patient management as a result of this issue.
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