The Recall Desk
ModerateFDA (Devices)·Z-2428-2017·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

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 describes a theoretical risk of antibiotic degradation due to moisture exposure without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for voluntary precautionary recalls or low-risk contamination where harm has not been reported.

Plain-English summary

Biomerieux Inc is voluntarily recalling 3,131 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-GN80), REF 413437. The recall is due to a potential compromise in the integrity of the product container, which may expose the cards to moisture. This exposure 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. 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 specify specific actions for consumers or healthcare providers beyond the recall notice. Users should verify the lot codes 6700244103 (dated 28/Jul/18) and 6700279203 (dated 01/Sep/18) against their inventory.

The recalled product

Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-GN80), REF 413437, 20 cards per carton.
Manufacturer
Biomerieux Inc
Category
Medical Device — Laboratory Test Kit
Hazard
Affected units
3,131

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)

  • 6700244103 28/Jul/18 6700279203 01/Sep/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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