Ortho-Clinical Diagnostics, Inc. VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through 6223. In vitro diagnostic -VITROS Chemistry Products Calibrator Kit 11 is used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of vancomycin (VANC). Product Code: 6801696 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing

Recommended Action

Per FDA guidance

QuidelOrtho (formerly Ortho Clinical Diagnostics) issued Urgent Product Correction Notification Letter on 4/14/23 to Distributors and End/Users. Letter states reason for recall, health risk and action to take: Prior to calibrating VITROS VANC Reagent GEN 50 using VITROS Calibrator Kit 11, Lot 1172, install ADD DRV 6224 or above on your VITROS System(s). " Complete the enclosed Confirmation of Receipt form no later than April 24, 2023. " Forward this notification if VITROS Calibrator Kit 11, Lot 1172 was distributed outside of your facility. " Save this notification with your user documentation or post this notification by each VITROS 5,1 FS/4600/5600/XT 7600 System until ADD DRV 6224 or above has installed. " If your laboratory has experienced the issue with this product and you have not already done so, please report the occurrence to your local Ortho Care" Technical Solutions Center. Contact Information If you have further questions, please contact the Ortho Care Technical Solutions Center at 1-800-421-3311.