VITEK® 2 0,45% Sodium Chloride DiluentRecalls & reported problems
Biomerieux , Inc. · VITEK 2.0 0.45% SALINE INDIVIDUAL BAG · Class 2
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 03573026556969), received between Feb 12, 2026 and Feb 12, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Incomplete or Missing Packaging” (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
- Incomplete or Missing Packaging1
Patient problems
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 12, 2026Incomplete or Missing Packaging
INTENDED USE: SALINE SOLUTION IS A DILUENT USED FOR MANUAL PREPARATION OF ORGANISM SUSPENSIONS, PRIOR TO IDENTIFICATION AND ANTIMICROBIAL SUSCEPTIBILITY PROCESSING WITH VITEK® 2 INSTRUMENTS. THE VITEK 2 0.45% SODIUM CHLORIDE DILUENT - 417820 IS NOT MANUFACTURED BY BIOMÉRIEUX. THIS ITEM IS A THIRD-PARTY PRODUCT MANUFACTURED BY PISA. ISSUE DESCRIPTION: A CUSTOMER IN AUSTRIA NOTIFIED BIOMÉRIEUX OF USER HARM RELATED TO VITEK 2 0.45% SODIUM CHLORIDE DILUENT (REF. 417820, LOT Q2410028 , EXP DATE 01-APRIL-2026). USER WAS INJURED WHILE MODIFYING A NEW VITEK 2 0.45% SODIUM CHLORIDE DILUENT TO BE PLACED IN THE VITEK 2 XL AS THE MOUNTING HOLE WAS TOO SMALL TO FIT ONTO THE MOUNTING PIN IN SIDE THE INSTRUMENT. THE USER ATTEMPTED TO ENLARGE THE HOLE WITH SCISSORS. DURING THIS SCISSORS USE, USER WAS INJURED; SHE OBTAINED A FINGER LACERATION WHICH NEEDED TO BE SUTURED AND UNDERWENT TREATMENT. USER IS UNABLE TO WORK FOR THREE WEEKS. NOTE: THE PRODUCT, VITEK 2 0.45% SODIUM CHLORIDE DILUENT - 417820, DID NOT DIRECTLY CAUSE THE INJURY. THE USE OF SCISSORS BY THE CUSTOMER TO MODIFY THE SALINE BAG WAS THE CAUSE OF THE INJURY. CUSTOMER ALSO INDICATED THAT THE USER MANUAL STATES THAT THE SALINE BAG HOLE N
Patient problems: Laceration(s)
MAUDE report 24326644 ↗
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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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