HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators (lyophilized) contain hemoglobin and glycated hemoglobin from human whole blood. Prior to lyophilization, the calibrator matrix is an MES-buffered solution. Preservative: Ofloxacin. For use in the calibration of the Hemoglobin A1c assay on the ARCHITECT c 8000 and c 4000 Systems.

Product Correction letters dated April 30, 2014 were sent to all customers. The letters included isntructions for customers to: 1) verify that the lot numbr listed on each calibrator bottle agrees with the lot number printed on the value sheet; 2) If HbA1c Calibrators lot 45063UQ12 has already been utilized in your laboratory, verify the concentrations configured for this calibrator lot match the values in the letter; 3) If these do not match, use the values in the letter when calibrating the HbA1c assay using calibrator lot 45063UQ12; and, 4) follow your laboratory protocol regarding the need for reviewing previously reported patient results if incorrect calibrator values were used.