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.
FDA Recall Z-1688-2021 · Posted None
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Recalling FirmOrtho-Clinical Diagnostics, INc.
Recall StatusTerminated
Product CodeQKP
Date Initiated2021-05-03
Date Terminated2023-10-24
Product Quantity74 units
Reason for Recall
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.
Firm Action
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.
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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