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Recall Observatory FDA recall evidence

Device 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.

Z-1688-2021

May 03, 2021

Class II

Product summary

Firm
Ortho-Clinical Diagnostics, INc.
Event
Event 87888
Status
Terminated
Classification
Class II
Quantity
74 units
Official record key
device-enforcement:Z-1688-2021

Official wording

Reason: 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.

Code information: Unique Identifier: 10758750033591 Lot: 0020

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.