The Recall Desk
HighFDA (Devices)·Z-2382-2017·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 causing antibiotic degradation.

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 medical device where a defect (moisture exposure) could lead to loss of potency, creating a risk of harm through inaccurate diagnostic results, but no injuries or illnesses have been reported.

Plain-English summary

Biomerieux Inc is voluntarily recalling 9,224 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-N190), REF 412548. 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, resulting in a loss of potency.

The affected product was distributed nationwide in the United States, including to military and government sites. The product 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 specific actions for consumers or healthcare providers, such as returning the product or contacting a specific support line. Users of the product should be aware that the antibiotic potency may be reduced, which could affect the accuracy of susceptibility testing results.

The recalled product

Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N190), REF 412548, 20 cards per carton.
Manufacturer
Biomerieux Inc
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
9,224

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)

  • 5600137203 12/Apr/18 5600171103 16/May/18 5600238103 22/Jul/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 · loss of potency

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