Ortho-Clinical Diagnostics, Inc.: VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. 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). Intended for Use in the United States Product Code: 6199949.

Recall number

Z-1266-2021

Recalling firm

Ortho-Clinical Diagnostics, Inc.

Product

VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. 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). Intended for Use in the United States Product Code: 6199949.

Status

Terminated

Initiated

2021-02-12

Posted

not on file

Terminated

2022-01-24

Reason

VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Viral Transport Media

Root cause

Under Investigation by firm

Action

Ortho Clinical issued Urgent Product Correction Notification letter on 12 February 2021 (CL2021-064) stated reason , health risk and action to take: Ortho is collaborating with the manufacturer of Remel M4RT VTM to identify the root cause of the issue. " Ortho no longer recommends use of Remel M4RT VTM with the VITROS SARS-CoV-2 Antigen assay. " The VITROS SARS-CoV-2 Antigen Instructions for Use has been updated to remove Remel M4RT VTM from the Intended Use and to also add WHO formulation, Bartels FlexTrans and saline. The revised assay IFU is located on our website: https://www.orthoclinicaldiagnostics.com. Our website is the official source of information for all VITROS Products. Refer to the Revision History section included at the end of each IFU for a comprehensive list of changes. Technical changes in each IFU are marked by a change bar (|) to the left of the edited text. Discontinue use of Remel M4RT VTM and transition to an alternate media. " As your facility transitions to an alternate transport media, Ortho advises that your facility confirm the performance of each new lot of Remel M4RT VTM by doing the following: o Test each lot of Remel M4RT VTM with no specimen added, with and without the addition of extraction buffer. Suitable lots of Remel M4RT VTM will produce S/C values consistent with the values observed for the VITROS SARS-CoV-2 Antigen Control 1. o If possible, confirm the first 5 samples that produce reactive results on the VITROS SARS-CoV-2 Antigen assay using polymerase chain reaction (PCR) methodology, for each new lot of Remel M4RT VTM. " Post this notification by each system that processes the VITROS SARS-CoV-2 Antigen assay. " Complete the enclosed Confirmation of Receipt form no later than February 22, 2021. " Please forward this notification if the product was distributed outside of your facility.

Quantity

2782 units

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.

Lot, serial or model codes

Any lot used with Remel M4RT VTM  UDI: 10758750033584

510(k) numbers

not on file

PMA numbers

not on file

Product code

QKP

Firm FEI

1000136573

Firm city

Rochester

Firm state

NY

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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