Ortho-Clinical Diagnostics, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1267-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

VITROS SARS-CoV-2 Antigen Reagent Pack - 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). Product Code: 6199941. OUS Product.

Product Classification:

Class II

Date Initiated: February 12, 2021

Date Posted: March 24, 2021

Recall Number: Z-1267-2021

Event ID: 87356

Reason for Recall:

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

Status: Terminated

Product Quantity: 12177 units

Code Information:

Any lot used with Remel M4RT VTM UDI: 10758750033584

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated