The Recall Desk
ModerateFDA (Devices)·Z-2525-2017·Announced 2017-06-21

Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers 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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a theoretical loss of potency due to moisture exposure, fitting the criteria for a moderate severity score.

Plain-English summary

Biomerieux Inc is voluntarily recalling VITEK 2 Gram Negative Susceptibility cards (AST-N364), Reference 421693. The recall is due to a potential compromise in the integrity of the product containers. This defect may expose the cards 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. The cards were 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 cartons or specific lot numbers beyond the reference code. Users should contact Biomerieux Inc for further instructions regarding the return or replacement of the affected product.

The recalled product

Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N364), IVD, REF 421693, 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)

  • 8140264403 17/Aug/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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