Biomerieux VITEK 2 Gram Negative Susceptibility Card Recall
Biomerieux is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may allow moisture exposure, leading to antibiotic degradation and loss of potency.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 or injuries. The hazard is a theoretical loss of potency due to moisture exposure, which aligns with the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls without reported harm.
Plain-English summary
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards (AST-N201), REF 412862. The recall involves 5,559 cartons, with 20 cards per carton. The product was distributed nationwide in the U.S., including military and government sites, as well as to numerous international locations.
The recall is being conducted because the integrity of the product container may be compromised. This compromise could expose the product to moisture, which may lead to antibiotic degradation and a loss of potency. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare facilities and consumers who have this product should stop using it and contact Biomerieux Inc for further instructions or a return.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-N201), REF 412862, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 5,559
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)
- 571375320 23/Dec/17 5710177103 22/May/18 5710208203 22/Jun/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 →- HighBiomerieux VITEK 2 AST-N461 Test Kit Recalled for Card Pouch Damage
FDA (Devices) · 2026-09-30
- 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
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
Similar recalls
- HighbioMerieux Recalls VITEK 2 Gram Positive Susceptibility Test Cards
FDA (Devices) · 2016-05-11
- ModerateBiomerieux Recalls VITEK 2 Gram-positive Susceptibility Cards Due to False Positives
FDA (Devices) · 2020-04-29
- SevereBiomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards for Labeling Error
FDA (Devices) · 2016-05-18
- ModeratebioMerieux Recalls VITEK 2 AST-N371 Cards Due to Compromised Seals
FDA (Devices) · 2020-04-01
- LowBiomerieux Recalls Vitek 2 AST-P641 Cards Due to Labeling Error
FDA (Devices) · 2015-04-15
- LowBiomerieux Recalls Vitek 2 Gram Positive Susceptibility Cards Due to Labeling Error
FDA (Devices) · 2015-04-15