Biomerieux Inc recalls VITEK¿ 2 Gram Positive Susceptibility card (AST-P641), IVD, REF 418590, 20 cards per carton.

Recalled June 21, 2017 · FDA recall Z-2488-2017 · Biomerieux

Hazard

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). · FDA Class II

Units

1,009 cartons

Sold at

Nationwide distribution in the U.S, including military and government sites. The product was also distributed to 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.

Description

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

Product

VITEK¿ 2 Gram Positive Susceptibility card (AST-P641), IVD, REF 418590, 20 cards per carton.

Manufacturer(s)

Biomerieux Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →