The Recall Desk
ModerateFDA (Devices)·Z-2469-2017·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 source text does not report any hospitalizations, injuries, or illnesses. The hazard is a theoretical loss of potency due to moisture exposure, which aligns with the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls without reported harm.

Plain-English summary

Biomerieux Inc is recalling 24,158 cartons of VITEK 2 Gram Positive Susceptibility cards (AST-GP75), REF 415670. The recall is due to a potential compromise in the integrity of the product container. This defect may expose the product to moisture, which 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.

The recall involves specific lot codes and dates, including 2750173203 (18/May/18), 2750179103 (24/May/18), 2750210203 (24/Jun/18), 2750222103 (06/Jul/18), 2750236103 (20/Jul/18), 2750236123 (20/Jul/18), 2750249103 (02/Aug/18), 2750277103 (30/Aug/18), and 2750285103 (07/Sep/18). Users should check their inventory for these specific codes and stop using the affected products.

The recalled product

Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-GP75), IVD, REF 415670, 20 cards per carton.
Manufacturer
Biomerieux Inc
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
24,158

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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