VIDAS® Refurbished 412590RRecalls & reported problems
Biomerieux SA · The VIDAS® 3 system is a complete standalone immunodiagnostic system using VIDAS reagent.The VIDAS® 3 system is not intended to be used with Industry VIDAS® reagents. · Class 1
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 03573026474317), received between Sep 10, 2026 and Sep 10, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Pumping Problem” (1 report).
4 other recalls cover devices cleared under the same FDA submission (K141133); they may or may not involve this specific model.
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
- Pumping Problem1
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.
MalfunctionSep 10, 2026Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721884 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K141133. One submission often covers many models, so check the product and lot details in each record.
- Z-0864-2023 · Nov 9, 2022 · Open, ClassifiedVIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01
- Z-0797-2023 · Nov 9, 2022 · Open, ClassifiedVIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226
- Z-0427-2022 · Sep 22, 2021 · Open, ClassifiedVIDAS DEX@, Dimer Exclusion II, REF 30455-01
- Z-0928-2020 · Oct 22, 2019 · TerminatedBIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
Other Analyzer, Chemistry (Photometric, Discrete), For Clinical Use devices
- Alinity 03R6701Abbott Laboratories · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE1 recall1 death1,197 reports
- Alinity 03R6501Abbott Laboratories · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE1 recall911 reports
- Atellica CH 930 Analyzer 11067000Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE5 recalls679 reports
- DxI 9000 Access Immunoassay Analyzer C11137Beckman Coulter, Inc. · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use17 recalls1 death3 reports
- ARCHITECT 3L77-01Abbott Laboratories · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE2 recalls1 death694 reports
- ARCHITECT 3M74-02Abbott Laboratories · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE1 recall650 reports
- ARCHITECT 2P24-40Abbott Laboratories · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE1 recall1 death646 reports
- cobas e 411 Immunoassay Analyzer 04775201001Roche Diagnostics GmbH · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE685 reports
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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