VITEK® 2 Pipetter/Diluter Accessories Kit 21219Recalls & reported problems
Biomerieux , Inc. · VITEK 2 Pipettor / Diluter Accessory Kit containing straws for VITEK 2 and VITEK 2 XL needed to prepare sample suspensions. · 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 03573026049782), received between Nov 14, 2025 and Nov 14, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Nonstandard Device” (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
- Nonstandard Device1
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 14, 2025Nonstandard Device; Nonstandard Device
INTENDED USE: VITEK 2 PIPETTOR / DILUTER ACCESSORY KIT CONTAINING PIPETTES FOR VITEK 2 AND VITEK 2 XL NEEDED TO PREPARE SAMPLE SUSPENSIONS. ISSUE DESCRIPTION: A CUSTOMER IN FRANCE NOTIFIED BIOMERIEUX OF DAMAGE AND DEFECT OBSERVED ON ACCESSORY KIT VTK2 PIP/DIL (REF. 21219, LOT 1011213650, EXP DATE 05-MARCH-2027. THE PIPETTOR/DILUTER KIT IS SEPARATED WHERE THE FLEXIBLE TUBING MEETS THE SHOT-TUBE FITTING. THE FITTING IS BROKEN OFF. THIS CAUSES INABILITY TO DISPENSE SALINE INTO THE AST SPECIMEN TUBES. WITHOUT THE PIPETTOR/DILUTOR ASSEMBLY, THE INSTRUMENT CANNOT PROCESS NEW SAMPLES. THE CUSTOMER STATED THAT ADDITIONAL NEW PIP/DIL ASSEMBLIES IN THE SHIPPING CONTAINER ARE ALREADY BROKEN AS WELL. AT THE TIME OF THE ASSESSMENT, THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23553420 ↗
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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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