Ortho-Clinical Diagnostics, INc. 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 CDCs formulation of VTM. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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 CDCs formulation of VTM.
Brand
Ortho-Clinical Diagnostics, INc.
Lot Codes / Batch Numbers
Unique Identifier: 10758750033591 Lot: 0020
Products Sold
Unique Identifier: 10758750033591 Lot: 0020
Ortho-Clinical Diagnostics, INc. is recalling VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay due to Ortho investigated and confirmed the potential for unexpected failed calibration, and condition codes associated with the calibration, when using VITR. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On May 4, 2021, Ortho Clinical Diagnostics issued an Urgent Medical Device Correction notice to customers via letter notifying them of calibration failures and the associated condition code for specified calibrator lots. Customers received the following instructions. " Discontinue using VITROS SARS-CoV-2 Antigen Reagent/Calibrator Lot 0064, discard any remaining inventory and switch to an alternate lot. " Ortho will credit and/or replace all remaining inventory of VITROS SARS-CoV-2 Antigen Reagent/Calibrator Lot 0064 as indicated on the Confirmation of Receipt form. " Complete the enclosed Confirmation of Receipt form no later than MM/DD/YY, even if your facility no longer has the affected product in inventory. " Please forward this notification if the product was distributed outside of your facility.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026