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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Immunodiagnostic Products SARSCoV2 Antigen Calibrator.

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  Class 2 Device Recall VITROS Immunodiagnostic Products SARSCoV2 Antigen Calibrator. see related information
Date Initiated by Firm May 03, 2021
Create Date May 27, 2021
Recall Status1 Open3, Classified
Recall Number Z-1688-2021
Recall Event ID 87888
Product Classification Coronavirus antigen detection test system. - Product Code QKP
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.
Code Information Unique Identifier: 10758750033591  Lot: 0020 
Recalling Firm/
Ortho-Clinical Diagnostics, INc.
513 Technology Blvd
Rochester NY 14626-3601
For Additional Information Contact Joe Falvo
Manufacturer 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.
FDA Determined
Cause 2
Under Investigation by 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.
Quantity in Commerce 74 units
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.