medical Class II Updated 2021-06-02

Ortho-Clinical Diagnostics, INc. recalls VITROS CoV2 Ag calibrator (Product Code 6199950) - Product

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Unique Identifier: 10758750033591 Lot: 0020
View official government recall

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