Oncomine™ Dx Express Test A50871Recalls & reported problems
Life Technologies Corporation · Class 3
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10190302017305), received between May 13, 2026 and May 13, 2026 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- False Negative Result1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2026False Negative Result
IT HAS BEEN DISCOVERED THAT THE ONCOMINE DX EXPRESS TEST (ODXET) MAY NOT DETECT THE FGFR3 C.746C>G P.S249C (COSM715) VARIANT WHEN PRESENT IN A SAMPLE AT VERY LOW ALLELIC FREQUENCIES (AFS) DUE TO A SECONDARY STRUCTURE FORMATION THAT INHIBITS AMPLIFICATION OF THE MUTANT ALLELE, WHICH MAY RESULT IN FALSE-NEGATIVE RESULTS FOR THIS SPECIFIC FGFR3 VARIANT DUE TO AF MEASUREMENT FALLING BELOW THE VARIANT CALLING THRESHOLD. PREDICTIVE MODELING INDICATES THIS IS DRIVEN BY HIGH GUANINE AND CYTOSINE (GC) CONTENT AROUND THE MUTATION SITE AND THE SHORTER AMPLICONS USED IN THE ODXET PANEL, WITH THE SPECIFIC C-TO-G CHANGE OCCURRING WITHIN A GC-RICH REGION THAT PROMOTES SUCH STRUCTURES. THIS EFFECT IS NOT OBSERVED IN WILDTYPE SAMPLES. THERMO FISHER HAS NOT BEEN MADE AWARE OF ANY DEATH, SERIOUS INJURY OR PERMANENT BODILY IMPAIRMENT OCCURRED FROM THE USE OF THE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25166741 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- 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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