FDAFDA · Food and drugs·Recall number Z-2461-2017
VITEK¿ 2 Gram Fungal Susceptibility card (AST-YS07), IVD, REF 414967, 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
- 2870115203 21/Mar/18 2870125203 31/Mar/18 2870129203 04/Apr/18 2870129223 04/Apr/18 2870143203 18/Apr/18 2870150203 25/Apr/18 2870157203 02/May/18 2870209403 23/Jun/18 2870221203 05/JUL/18 2870235203 19/Jul/18 2870241203 25/Jul/18 2870241223 25/Jul/18 2870248403 01/Aug/18 2870276203 29/Aug/18 2870283103 05/Sep/18 2870283203 05/Sep/18
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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