FDAFDA · Food and drugs·Recall number Z-2372-2017
VITEK¿ 2 Gram Streptococcus Susceptibility card (AST-ST01), REF 410028, 20 cards per carton.
Published June 21, 2017 · Recall initiated: April 20, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Biomerieux Inc
- Distributor
- 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.
- Lot
- 5400115203 21/Mar/18 5400122223 28/Mar/18 5400136203 11/Apr/18 5400136223 11/Apr/18 5400136243 11/Apr/18 5400143203 18/Apr/18 5400192203 06/Jun/18 5400192223 06/Jun/18 5400192243 06/Jun/18 5400199203 13/Jun/18 5400216203 30/Jun/18 5400221203 05/Jul/18 5400238203 22/Jul/18 5400238223 22/Jul/18 5400238243 22/Jul/18 5400262223 15/Aug/18 5400269203 22/Aug/18 5400276203 29/Aug/18 5400276213 29/Aug/18 5400283203 05/Sep/18 5400283213 05/Sep/18
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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