VITROS 6199960Recalls & reported problems
Ortho Clinical Diagnostics · VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Reagent Pack · Class N
Data updated Oct 13, 2026 from official FDA records · Editorial policy
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
- May 26, 2022Open, Classified
On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).
Z-1367-2022 · Root cause: Incorrect or no expiration date · FDA record ↗
Other Reagent, coronavirus serological devices
- Access SARS-CoV-2 IgG C58961Beckman Coulter, Inc. · Reagent, Coronavirus Serological57 reports
- VITROS 6199976Ortho-Clinical Diagnostics, Inc. · 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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