VERSANT® kPCR Molecular System SP 10282928Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · VERSANT® kPCR Molecular System Sample Preparation Instrument Module · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00630414541457), received between Feb 18, 2021 and Feb 19, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (3 reports).
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 Positive Result3
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 19, 2021False Positive Result; False Positive Result
THE CUSTOMER OBSERVED FALSELY-ELEVATED RESULTS FOR THE FTD SARS-COV-2 ASSAY AS A RESULT OF CONTAMINATION OF THE VERSANT KPCR MOLECULAR SYSTEM SP. [FAST TRACK DIAGNOSTICS (FTD) IS A SIEMENS HEALTHINEERS COMPANY.] THE SAMPLES IN QUESTION WERE RE-TESTED USING AN ALTERNATE SYSTEM, AND PRODUCED NEGATIVE RESULTS, WHICH WERE REPORTED AS CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT SARS-COV-2 RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11351252 ↗MalfunctionFeb 19, 2021False Positive Result; False Positive Result
THE CUSTOMER OBSERVED FALSELY-ELEVATED RESULTS FOR THE FTD SARS-COV-2 ASSAY AS A RESULT OF CONTAMINATION OF THE VERSANT KPCR MOLECULAR SYSTEM SP. [FAST TRACK DIAGNOSTICS (FTD) IS A SIEMENS HEALTHINEERS COMPANY.] THE SAMPLES IN QUESTION WERE RE-TESTED USING AN ALTERNATE SYSTEM, AND PRODUCED NEGATIVE RESULTS, WHICH WERE REPORTED AS CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT SARS-COV-2 RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11351110 ↗MalfunctionFeb 19, 2021False Positive Result; False Positive Result
THE CUSTOMER OBSERVED FALSELY-ELEVATED RESULTS FOR THE FTD SARS-COV-2 ASSAY AS A RESULT OF CONTAMINATION OF THE VERSANT KPCR MOLECULAR SYSTEM SP. [FAST TRACK DIAGNOSTICS (FTD) IS A SIEMENS HEALTHINEERS COMPANY.] THE SAMPLES IN QUESTION WERE RE-TESTED USING AN ALTERNATE SYSTEM, AND PRODUCED NEGATIVE RESULTS, WHICH WERE REPORTED AS CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT SARS-COV-2 RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11351080 ↗MalfunctionFeb 18, 2021Use of Device Problem; Use of Device Problem
THE CUSTOMER OBSERVED ASSIGNMENT OF AN INVALID PATIENT ID TO A RESULT RECORD WHEN USING THE VERSANT KPCR MOLECULAR SYSTEM SP, DUE TO AN APPARENT BARCODE-READING ERROR. THE INCORRECT ID WAS APPARENT TO THE USER, AND DID NOT LEAD TO ANY LOSS OR MISDIRECTION OF RESULT DATA. THE ERROR WAS CORRECTED WITHOUT CONSEQUENCE. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE OBSERVED ERROR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11345886 ↗
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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.
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