VITROS 6199976Recalls & reported problems
Ortho-Clinical Diagnostics, Inc. · VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators · Class N
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Mar 9, 2023Open, Classified
Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks (ADD), resulting in delayed patients results
Z-1396-2023 · Root cause: Employee error · FDA record ↗
Other Reagent, coronavirus serological devices
- Access SARS-CoV-2 IgG C58961Beckman Coulter, Inc. · Reagent, Coronavirus Serological57 reports
- VITROS 6199960Ortho Clinical Diagnostics · Reagent, coronavirus serological1 recall0 reports
- Access SARS-CoV-2 IgG QC C58964Beckman Coulter, Inc. · Reagent, Coronavirus Serological1 recall0 reports
- Access SARS-CoV-2 IgG II C69057Beckman Coulter, Inc. · Reagent, Coronavirus Serological33 reports
- ARCHITECT 06R8620Abbott Laboratories · Reagent, coronavirus serological16 reports
- Access SARS-CoV-2 IgM C58957Beckman Coulter, Inc. · Reagent, Coronavirus Serological13 reports
- ARCHITECT 06R8630Abbott Laboratories · Reagent, coronavirus serological3 reports
- Alinity 06R9020Abbott Laboratories · Reagent, coronavirus serological2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.