Ortho-Clinical Diagnostics, Inc. Recall 87356
Description: 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). Product Code: 6199941. OUS Product.
Ortho-Clinical Diagnostics, Inc. Recall 87356 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1267-2021 |
| Event ID | 87356 |
| Event Description | 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). Product Code: 6199941. OUS Product. |
| Product Type | Devices |
| 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. |
| Quantity | 12177 units |
| Recall Reason | VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Viral Transport Media |
| Device Classification | 20210324 |
| Device Code Info | Any lot used with Remel M4RT VTM UDI: 10758750033584 |
| Center Classification Date | 20210317 |
| Recall Initiation Date | 20210212 |
| Recalling Firm | Ortho-Clinical Diagnostics, Inc. |
| Initial Notification | Letter |
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