QUANTA-Lyser ® 3000 ELISA/IFA+ Incubator VS3000iRecalls & reported problems
Inova Diagnostics, Inc. · QUANTA-Lyser instruments are fully automated benchtop processors for use in conjunction with certain reagents to measure a variety of analytes. QUANTA-Lyser is intended to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting medium in preparation for microscope analysis and photometric measurement of microwell plates. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08426950865100), received between Jul 24, 2025 and Jul 24, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “False Positive 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.
Reports received per month
Most reported problems
Device problems
- False Positive 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.
InjuryJul 24, 2025False Positive Result; False Positive Result
A CUSTOMER REPORTED A POTENTIAL OPERATOR ERROR DURING USE OF THE QUANTA-LYSER® 3000 ELISA/IFA+ INCUBATOR (PART NUMBER: VS3000I, SERIAL NUMBER: (B)(6). THE INSTRUMENT ALLOWS MULTIPLE WASH BUFFERS TO BE USED SIMULTANEOUSLY. THE SOFTWARE GUIDES THE OPERATOR TO PLACE THE CORRECT WASH BUFFER LINE IN THE WASH BUFFER CONTAINER. THE CUSTOMER ALLEGES THE INCORRECT WASH BUFFER LINE MAY HAVE BEEN PLACED IN THE WASH BUFFER CONTAINER DURING INSTRUMENT SETUP RESULTING IN THE INCORRECT WASH BUFFER BEING DELIVERED FOR QUANTA LITE® ACTIN IGG (P/N: 708785) AND QUANTA LITE® M2 EP (MIT3) (P/N: 704540). THE ERROR, ATTRIBUTED TO A SINGLE OPERATOR, WAS SUSPECTED TO HAVE OCCURRED DURING TESTING CONDUCTED IN (B)(6) 2025. THE CUSTOMER ALLEGES THIS ERROR MAY HAVE CONTRIBUTED TO AN INCREASED POSITIVITY IN PATIENTS. THE CUSTOMER REPORTED THAT, DURING THE SPECIFIED TIMEFRAME, A TOTAL OF 174 PATIENT SAMPLES WERE TESTED ACROSS BOTH ASSAYS BY ALL OPERATORS. THE CUSTOMER ALSO NOTED THAT ELEVEN PATIENTS UNDERWENT LIVER BIOPSY. HOWEVER, IT IS UNKNOWN WHETHER THE ASSAY RESULTS CONTRIBUTED TO OR INFLUENCED THE DECISION TO PERFORM THE BIOPSIES. PATIENT CLINICAL HISTORY HAS NOT PROVIDED AND EFFORTS TO OBTAIN THIS INFORMA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22586682 ↗
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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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