The Recall Desk
ModerateFDA (Devices)·Z-2516-2017·Announced 2017-06-21

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, but the source text explicitly states no illnesses or injuries have been reported. The hazard is a theoretical loss of potency due to moisture exposure, which aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures without reported harm.

Plain-English summary

Biomerieux Inc is recalling 511 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-N353), Reference 421297. The recall involves 20 cards per carton. The product is an in vitro diagnostic (IVD) device used for susceptibility testing.

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 source text does not report any illnesses, injuries, or deaths associated with this recall.

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.

The recalled product

Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N353), IVD, REF 421297, 20 cards per carton.
Manufacturer
Biomerieux Inc
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
511

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)

  • 7930118203 24/Mar/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 →

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Same hazard · moisture exposure

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