Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues 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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential loss of potency without confirmed adverse events.
Plain-English summary
Biomerieux Inc is recalling 552 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-N320), REF 418204. The recall was initiated because the integrity of the product container may be compromised, which could expose the product to moisture. This exposure could 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.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-N320), IVD, REF 418204, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 552
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)
- 7600203103 17/Jun/18
Distribution
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.
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