ARIES® HSV 1&2 Assay 50-10017Recalls & reported problems
Luminex Corporation · The ARIES® HSV 1 & 2 Assay is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus (HSV) DNA from cutaneous and mucocutaneous lesion swab specimens. · Class 2
Data updated Oct 18, 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 00840487100295), received between Nov 4, 2021 and Nov 4, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Body Fluid” (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
- Device Contamination with Body Fluid1
- Fluid/Blood Leak1
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.
MalfunctionNov 4, 2021Fluid/Blood Leak; Device Contamination with Body Fluid
ON SEPTEMBER 27, 2021 FIELD QUALITY ASSURANCE NOTIFIED REGULATORY AFFAIRS OF THE CUSTOMER (B)(6) OBSERVING LEAKS WHILE USING ARIES HSV 1&2 ASSAY - IVD (PART NUMBER 50-10017, LOTS AB3600A AND AB3560A) FOLLOWING SAMPLE RUNS. THE CUSTOMER REPORTED RESIDUE BUILDUP ON THE ACTUATION BLOCK AND VALVE KEYS OF THEIR ARIES SYSTEMS. ARIES ASSAY CASSETTES ARE DESIGNED TO BE A SEALED AND CONTAINED PRODUCT. WITHIN THE CASSETTE, SAMPLE PREPARATION AND WASHING UTILIZES A SERIES OF REAGENTS TO LYSE AND PURIFY HUMAN DNA FOR PCR ANALYSIS. CASSETTES THAT LEAK WHILE BEING UTILIZED HAVE THE POTENTIAL TO LEAK THE INTERNAL REAGENTS AND PATIENT SAMPLE INTO THE ARIES SYSTEM AND THE ARIES MAGAZINE THAT LOADS INTO THE INSTRUMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12753939 ↗
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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