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
- Company
- Ortho Clinical Diagnostics Inc
- Recall Initiated
- April 14, 2023
- Posted
- May 30, 2023
- Recall Number
- Z-1664-2023
- Quantity
- 132 units
- Firm Location
- Raritan, NJ
Reason for Recall
Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing
Distribution
Nationwide Foreign: Brazil, Chile, Colombia
Lot / Code Info
UDI-DI: 10758750006601 Lot Number: 1172 Exp. 20-OCT-2023
Root Cause
Under Investigation by firm
Action Taken
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.