Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
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 hazard is limited to potential loss of potency due to moisture exposure rather than direct physical injury or contamination, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomerieux Inc is voluntarily recalling 4,012 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-N254), REF 413723. The recall is due to a potential defect where the integrity of the product container may be compromised. This defect could expose the product to moisture, which may lead to antibiotic degradation and a loss of potency.
The affected product was distributed nationwide in the United States, including to military and government sites. It was also distributed to numerous international locations, including Canada, the United Kingdom, Australia, and various countries in Europe, Asia, Africa, and the Americas. The specific lot codes associated with the recall are 6540146203, 6540252103, and 6540290203.
Healthcare facilities and distributors should stop using the affected cards and contact Biomerieux Inc for instructions on how to return the product. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-N254), REF 413723, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 4,012
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)
- 6540146203 21/Apr/18 6540252103 05/Aug/18 6540290203 12/Sep/18
Distribution
Part of a larger recall action
This product is one of 187 recalled by Biomerieux Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 187 products in this recall →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
- ModeratebioMerieux Recalls VITEK 2 AST-N371 Cards Due to Compromised Seals
FDA (Devices) · 2020-04-01
- 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