bioMerieux Recalls VITEK 2 AST-N371 Cards Due to Compromised Seals
bioMerieux is recalling 4,130 kits of VITEK 2 AST-N371 cards because compromised top seals may allow moisture to enter, potentially affecting antibiotic performance.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a potential impact on antibiotic performance due to moisture, which fits the criteria for a moderate severity recall involving a theoretical or low-risk contamination/defect without reported harm.
Plain-English summary
bioMerieux, Inc. is recalling 4,130 kits (82,600 cards) of VITEK 2 card AST-N371. The VITEK 2 is an automated system used for the identification and antimicrobial susceptibility testing of bacteria and yeast. The specific lot number is 0210932204, and the reference number is 422024.
The recall was initiated because the top seal of some of the pouches was compromised. This defect can allow moisture to enter the packaging, which may impact some antibiotics on the card. The affected products were distributed internationally in Germany and the Netherlands.
This is a Class II recall. No illnesses or injuries have been reported in connection with this recall. Users should stop using the affected cards and contact bioMerieux, Inc. for further instructions or replacement.
The recalled product
- Product
- VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns
- Manufacturer
- bioMerieux, Inc.
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 (1)
- REF: 422024 Lot Number: 0210932204
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 · moisture exposure
See all →- HighEchelon-14 Micro Catheter Recall Due to Moisture Exposure During Transport
FDA (Devices) · 2022-08-24
- ModerateTeleflex Recalls RUSCH LASERTUBE Devices Due to Laser Guard Foil Separation
FDA (Devices) · 2020-07-15
- ModerateAmerican Health Packaging Recalls Desmopressin Acetate Tablets Due to Missing Desiccant
FDA (Drugs) · 2020-02-26
- ModeratePfizer Recalls Caduet Tablets Due to Defective Bottle Seals
FDA (Drugs) · 2020-02-19
- ModeratePfizer Recalls Caduet Tablets Due to Defective Bottle Seals
FDA (Drugs) · 2020-02-19