Access SARS-CoV-2 IgG QC C58964Recalls & reported problems
Beckman Coulter, Inc. · The Access SARS-CoV-2 IgG QC is intended for monitoring system performance of the Access SARS-CoV-2 IgG assay. The Access SARS-CoV-2 IgG QC is for use on the Access Family of Immunoassay Systems only. The Access SARS-CoV-2 IgG QC are only for use under the Food and Drug Administration's Emergency Use Authorization. · Class N
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Dec 30, 2020Class IITerminated
The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC.
Z-0875-2021 · Root cause: Labeling mix-ups · Recall details · 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
- VITROS 6199976Ortho-Clinical Diagnostics, 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
- Dimension CV2T Assay 11417412Siemens Healthcare Diagnostics Inc. · Reagent, coronavirus serological2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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