The Recall Desk
ModerateFDA (Devices)·Z-2453-2017·Announced 2017-06-21

Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Moisture Risk

Biomerieux Inc is recalling VITEK 2 Gram Positive 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 hazard is limited to potential loss of potency due to moisture exposure rather than direct physical injury or contamination with harmful pathogens. No illnesses or injuries are reported, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Biomerieux Inc is recalling 1,221 cartons of VITEK 2 Gram Positive Susceptibility cards (AST-P628), REF 414534. 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 and a loss of potency.

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 specify specific actions for consumers or healthcare providers beyond the recall notice itself. The product is identified by the code 5380116203 22/Mar/18.

The recalled product

Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-P628), REF 414534, 20 cards per carton.
Manufacturer
Biomerieux Inc
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
1,221

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)

  • 5380116203 22/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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