Recall Z-1267-2021 ยท QKP Coronavirus Antigen Detection Test System.
Ortho-Clinical Diagnostics, Inc.
VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) specimens. For emergency authorization use only (EAU)
| Date | Feb 12, 2021 |
| Status | Terminated |
| Reason | VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Viral Transport Media |
| Root cause | Under Investigation by firm |
| Action | Ortho Clinical issued Urgent Product Correction Notification letter on 12 February 2021 (CL2021-064) stated reason , health risk and action to take: Ortho is collaborating with the manufacturer of Remel M4RT VTM to identify the root cause of the issue. " Ortho no longer recommends use of Remel M4RT VTM with the VITROS SARS-CoV-2 Antigen assay. " The VITROS SARS-CoV-2 Antigen Instructions for Use has been updated to remove Remel M4RT VTM from the Intended Use and to also add WHO formulation, Bartels FlexTrans and saline. The revised assay IFU is located on our website: https://www.orthoclinic |
| Quantity | 12177 units |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Canada L3R 4G5, Chile, Colombia, Denmark, France, Germany, India, Italy, Japan, Portugal, Russia, Singapore 609917, Spain, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.