The Recall Desk
ModerateFDA (Devices)·Z-2449-2017·Announced 2017-06-21

Biomerieux VITEK 2 Gram Negative Susceptibility Card Recall

Biomerieux is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may allow moisture exposure, 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 toxicity risk, fitting the Moderate criteria for low-risk contamination or functional issues without reported harm.

Plain-English summary

Biomerieux Inc is recalling 477 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-N276, REF 414286). The recall was initiated because the integrity of the product container may be compromised, which could expose the product to moisture. This exposure 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 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.

Users should stop using the affected product and contact Biomerieux Inc for further instructions or a replacement.

The recalled product

Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N276), REF 414286, 20 cards per carton.
Manufacturer
Biomerieux Inc
Category
Medical Device — Laboratory Diagnostic
Hazard
Affected units
477

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)

  • 6960139203 14/Apr/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

Same manufacturer · Biomerieux Inc

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Same hazard · moisture exposure

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