PlainRecalls
FDA Devices Moderate Class II Terminated

VITEK 2 Gram Negative Susceptibility card (AST-GN16), REF 22139, 20 cards per carton.

Reported: June 21, 2017 Initiated: April 20, 2017 #Z-2351-2017

Product Description

VITEK 2 Gram Negative Susceptibility card (AST-GN16), REF 22139, 20 cards per carton.

Reason for Recall

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

Details

Recalling Firm
Biomerieux Inc
Units Affected
9,817 cartons
Distribution
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.
Location
Hazelwood, MO

Frequently Asked Questions

What product was recalled?
VITEK 2 Gram Negative Susceptibility card (AST-GN16), REF 22139, 20 cards per carton.. Recalled by Biomerieux Inc. Units affected: 9,817 cartons.
Why was this product recalled?
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
Which agency issued this recall?
This recall was issued by the FDA Devices on June 21, 2017. Severity: Moderate. Recall number: Z-2351-2017.