Z-1266-2021 Class II Terminated
FDA device recall Z-1266-2021 was initiated by Ortho-Clinical Diagnostics, Inc. on February 12, 2021 and is designated Class II. Reason for recall: VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Viral Transport Media The recall status is terminated (terminated January 24, 2022). Affected quantity: 2782 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 24, 2021
- Initiation Date
- February 12, 2021
- Termination Date
- January 24, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2782 units
Product Description
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.
Reason for Recall
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Viral Transport Media
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.
Code Information
Any lot used with Remel M4RT VTM UDI: 10758750033584