Biomerieux VITEK 2 AST-N461 Test Kit Recalled for Card Pouch Damage
Biomerieux Inc is recalling VITEK 2 AST-N461 test kits due to card pouch damage that may cause false resistant results, potentially leading to less effective antibiotic treatments.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (incorrect antibiotic treatment) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Biomerieux Inc is recalling 97,680 units of the VITEK 2 AST-N461 Test Kit, Gram Negative Susceptibility Testing - Automated (Reference Number 424811). The recall is due to card pouch damage associated with a portion of the lot produced on a specific card pouching device during a specific timeframe.
The damaged card pouches create a potential risk of false resistant results. These inaccurate results may lead to the use of less effective antibiotic treatments or the association of multiple antibiotics with negative side effects, which could potentially impact patient health.
The affected products were distributed internationally to Austria, Germany, and Luxembourg. The specific lot number is 1333393504, and the UDI-DI is 03573026637712. Healthcare facilities and consumers should stop using the affected test kits and contact Biomerieux Inc for further instructions.
The recalled product
- Product
- VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
- Manufacturer
- Biomerieux Inc
- Affected units
- 97,680
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI 03573026637712
- Lot Number 1333393504
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Biomerieux Inc
See all →- HighVITEK 2 AST-N447 Test Kit Potentially Returns False Resistant Results
FDA (Devices) · 2026-07-15
- HighSusceptibility test cards recalled over false resistant antibiotic results
FDA (Devices) · 2026-02-11
- HighAntimicrobial susceptibility test cards recalled over false colistin resistance results
FDA (Devices) · 2025-10-08
- SevereVITEK 2 AST Test Kits: Ceftriaxone Concentration Error Risk
FDA (Devices) · 2024-05-01
- HighMedical Device Middleware: MYLA Software Fails to Apply AST Filter Rules
FDA (Devices) · 2023-03-08
Same hazard · false test result
See all →- HighEstrone RIA Diagnostic Kit Recall by Immunotech A.S.
FDA (Devices) · 2026-02-25
- SevereBD BACTEC MGIT 960 PZA Kit tuberculosis susceptibility testing recall
FDA (Devices) · 2025-07-02
- HighMedline Stat-Site B-HB Diluent Recalled for Potential Test Inaccuracy
FDA (Devices) · 2021-04-21
- SevereBiomerieux Recalls VITEK 2 Systems Due to HL7 Software Defect
FDA (Devices) · 2021-03-31
- HighBeckman Coulter MicroScan Pos MIC Panel Type 34 Recalled for QC Failure
FDA (Devices) · 2020-12-30
Similar recalls
- HighVITEK 2 AST-N447 Test Kit Potentially Returns False Resistant Results
FDA (Devices) · 2026-07-15
- ModerateBiomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards
FDA (Devices) · 2017-06-21
- ModerateBiomerieux VITEK 2 Gram Negative Susceptibility Card Container Integrity Recall
FDA (Devices) · 2017-06-21
- ModerateBiomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Container Integrity
FDA (Devices) · 2017-06-21
- ModeratebioMerieux Recalls VITEK 2 AST-N371 Cards Due to Compromised Seals
FDA (Devices) · 2020-04-01
- ModerateBiomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
FDA (Devices) · 2017-06-21