Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because container integrity issues may expose the product to moisture, potentially degrading antibiotic potency.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 the hazard is a loss of potency (antibiotic degradation) due to moisture exposure. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' as the device may fail to provide accurate susceptibility results, potentially leading to inappropriate treatment, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Biomerieux Inc is recalling 490 cartons of VITEK 2 Gram Positive Susceptibility cards (AST-P613, REF 410027). 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. 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.
Healthcare facilities and consumers should stop using the affected cards and contact Biomerieux Inc for further instructions or a replacement.
The recalled product
- Product
- VITEK¿ 2 Gram Positive Susceptibility card (AST-P613), REF 410027, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 490
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)
- 4930186403 31/May/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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