FDAMay 22, 2019device

"HEMOGLOBIN A1c CALIBRATORS * REF 4P52-01 * 307261/R03 * S4P5X0 * FOR USE WITH ARCHITECT" - Product Usage: use in the calibration of the Hemoglobin A1c assay.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The manufacturer observed no impact to assay performance between the HbA1c concentration range of 5.33% to 6.87%. However, outside of this range, a bias of greater than 3% may be seen with patient results. The device failure that is associated with this recall can result in potentially negatively and positively biased patient test results for HbA1c. The firm is investigating the root cause.

What to do

FDA enforcement status: Terminated

Brands named

abbott laboratoriesabbott

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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