Recall Z-1688-2021— Ortho-Clinical Diagnostics, INc.
Class II · Terminated
Class II FDA medical device recall by Ortho-Clinical Diagnostics, INc., initiated 2021-05-03, terminated 2023-10-24. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Ortho-Clinical Diagnostics, INc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-05-03
- Terminated
- 2023-10-24
- Firm location
- Rochester, NY, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.