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 degrading antibiotic potency.
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. The hazard involves potential loss of potency due to moisture exposure, which is a functional defect rather than a direct physical injury or acute toxicological hazard. No illnesses or injuries are reported in the source text.
Plain-English summary
Biomerieux Inc is recalling 7,717 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-GN79), REF 413436. The recall involves four specific lot codes: 5990174103, 5990238103, 5990251103, and 5990267203.
The recall was initiated because 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 product is a medical device used for susceptibility testing.
The affected products were distributed nationwide in the U.S., including to military and government sites, as well as to numerous international locations. Users should check their inventory for the specific lot codes listed and contact Biomerieux Inc for further instructions on handling or returning the product.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-GN79), REF 413436, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 7,717
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