Recall Z-0120-2022 ยท QKO Reagent, Coronavirus Serological
Ortho Clinical Diagnostics Inc
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti- SARS-CoV-2 IgG
| Date | Sep 10, 2021 |
| Status | Terminated |
| Reason | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results |
| Root cause | Under Investigation by firm |
| Action | Ortho Clinical Diagnostics issued on 10 September 2021 an "Important Product Correction Notification" letter to consignees who received VITROS Anti-SARS-CoV-2 IgG Quantitative Control, lot 0040 (Ref. CL2021-235) stating reason for notification, health risk and action to take: While the accuracy of patient test results is not affected by this issue, there is a potential for delayed results due to the troubleshooting of Quality Control results. If standard troubleshooting does not resolve the out-of-range QC results, your facility would be unable to utilize the VITROS Anti-SARS-CoV-2 IgG Quanti |
| Quantity | US: 64 OUS: 200 |
| Distribution | Worldwide Distribution: US (Nationwide) in states of: AL, AR, AZ, CA, CO, DC, FL, ID, KS, KY, LA, ME, MI, MS, MO, NY, TN, TX and WV; and OUS (Foreign) in countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany, Italy, Spain, P |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.