The VITROS Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunction with: VITROS Chemistry Products HbA1c Reagent Kit, Generation 6 (GEN 6) and Assay Data Disk (ADD), Data Release Versions (DRV) 5873, 5874, 5875, or 5876, is used to calibrate the VITROS 5,1 FS Chemistry System, VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the determination of percent glycated hemoglobin (HbA1c) in human whole blood.

There is an incorrect value (data/calibration mathematics) on ADDs. This incorrect value will prevent a successful calibration of the assay.

On 19 April 2016, Ortho Clinical Diagnostics distributed Correction Notification letters (Ref. CL2016-087) and ADD DRV 5877 notices to their US consignees via courier service and to their foreign affiliates via email. Customers were advised to install the Assay Data Diskette DRV 5877 or above on their VITROS system. Following a successful calibration and quality control assessment, it is acceptable to use VITROS HbA1c Reagent Kit, GEN 06. Customers who further distributed the product should also provide a copy of the enclosed letter to all customers who received the product. It is suggested that customers complete and return the Confirmation of Receipt form to indicate that you have been informed of this issue. Customers with questions can contact the Technical Solutions Center at 1-800-421-3311.