Recall Z-1396-2023
Ortho-Clinical Diagnostics, Inc. · initiated March 9, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Versions (DRV): DRVs 6213 through 6218 supporting VITROS Calibrators. Product Code: 6199976
Codes / lots: UDI: 10758750034581 Lot # /Expiration Date: 0230 22-Feb-2023; 0240 22-Mar-2023; 0250 26-Apr-2023.
Reason for recall
Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks (ADD), resulting in delayed patients results
FDA-determined cause: Employee error
Action taken
Ortho Clinical Diagnostics issued Important Product Correction Notification letter on 3/9/23. Letter states reason for recall, health risk and action to take: To calibrate all lots currently within expiring date of Anti-SARS-CoV-2 Total N, load ADD 6219 or higher on your VITROS System. " Complete the enclosed Confirmation of Receipt form no later than March 17, 2023. " Please forward this notification and ADD if the affected product was distributed outside of your facility. " 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. If you have further questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
Details
- Recall number
- Z-1396-2023
- Initiated
- March 9, 2023
- Posted by FDA
- April 18, 2023
- Product code
- QKO – Reagent, Coronavirus Serological
- Quantity
- 256 units
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, GA, NY.
- Recalling firm
- Ortho-Clinical Diagnostics, Inc., Raritan, NJ