Dimension CV2T Assay 11417412Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · Dimension CV2T Assay · Class N
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00630414605418), received between May 14, 2021 and Oct 25, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (1 report).
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.
Most reported problems
Device problems
- False Negative Result1
- False Positive Result1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 25, 2021False Negative Result; False Negative Result
A DISCORDANT NEGATIVE DIMENSION SARS-COV-2 TOTAL ANTIBODY (CV2T) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION EXL 200 SYSTEM. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME PATIENT SAMPLE WAS REPROCESSED ON THE SAME SYSTEM THE NEXT DAY AND A POSITIVE RESULT, CONSIDERED CORRECT, WAS OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DIMENSION CV2T PATIENT SAMPLE RESULT THAT WAS NOT REPORTED TO THE PHYSICIAN(S).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12688522 ↗MalfunctionMay 14, 2021False Positive Result; False Positive Result
THE CUSTOMER CONSIDERED A POSITIVE DIMENSION SARS-COV-2 TOTAL ANTIBODY (CV2T) RESULT ON A PATIENT SAMPLE ON A DIMENSION EXL 200 SYSTEM TO BE DISCORDANT. THE PATIENT RESULT WAS NOT REPORTED. THE SAME PATIENT SAMPLE WAS SENT TO AN ALTERNATE LABORATORY AND PROCESSED ON A NON-SIEMENS METHODOLOGY. A NEGATIVE RESULT WAS OBTAINED AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DIMENSION CV2T PATIENT RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11824524 ↗
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 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
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 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page