The Recall Desk
ModerateFDA (Devices)·Z-2479-2017·Announced 2017-06-21

Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

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 without reports of injury or illness, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards (AST-N315), Reference 417426, which are in vitro diagnostic (IVD) devices. The recall is due to a potential compromise in the integrity of the product container. This defect may expose the product to moisture, which could 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 Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia - Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroun, Canada, Chad, Chile, China, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Gambia, Georgia, Germany, Greece, Grenada, Guatemala, Guinea, Haiti, Honduras, Hungary, India, Indonesia, Iraq, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Uganda, Kuwait, Laos, Latvia, Lebanon, Lithuania, Malaysia, Mali, Malta, Mexico, Mongolia, Morocco, Mozambique, Myanmar, Netherlands, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Zimbabwe.

The source text does not specify the number of affected units or provide specific instructions for consumers or healthcare providers on how to handle the recalled product.

The recalled product

Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N315), IVD, REF 417426, 20 cards per carton.
Manufacturer
Biomerieux Inc
Category
Medical Device — In Vitro Diagnostics
Hazard

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)

  • 7550202403 16/Jun/18

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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

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Same hazard · moisture exposure

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