Recall Z-1396-2023 ยท QKO Reagent, Coronavirus Serological
Ortho-Clinical Diagnostics, Inc.
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
| Date | Apr 18, 2023 (initiated Mar 9, 2023) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Employee error |
| Action | 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 oc |
| Quantity | 256 units |
| Distribution | US Nationwide distribution in the states of AL, AZ, CA, GA, NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.