Ortho-Clinical Diagnostics, INc. Recall 87888
Description: VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) and anterior nasal swab specimens collected in CDC s formulation of VTM.
Ortho-Clinical Diagnostics, INc. Recall 87888 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1688-2021 |
| Event ID | 87888 |
| Event Description | VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) and anterior nasal swab specimens collected in CDC s formulation of VTM. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AR, CA, IA, IL, LA, MO, MS, TX, WI, and the countries of Colombia, India, Japan, Italy, Spain, Portugal, France. |
| Quantity | 74 units |
| Recall Reason | Ortho investigated and confirmed the potential for unexpected failed calibration, and condition codes associated with the calibration, when using VITROS SARS-CoV-2 Ag Reagent Pack along with VITROS Immunodiagnostic Products SARS-CoV-2 Ag Calibrator, Lot 20. |
| Device Classification | 20210602 |
| Device Code Info | Unique Identifier: 10758750033591 Lot: 0020 |
| Center Classification Date | 20210527 |
| Recall Initiation Date | 20210503 |
| Recalling Firm | Ortho-Clinical Diagnostics, INc. |
| Initial Notification | Letter |
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