The Recall Desk
HighFDA (Devices)·Z-2499-2017·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 allow moisture exposure, leading to antibiotic degradation and loss of potency.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Biomerieux Inc is recalling 505 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-N335), REF 418985. 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 specific illnesses, injuries, or deaths associated with this recall.

The affected product was distributed nationwide in the U.S., 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 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-N335), IVD, REF 418985, 20 cards per carton.
Manufacturer
Biomerieux Inc
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
505

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)

  • 7750260203 13/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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