FDAFDA · Food and drugs·Recall number Z-2353-2017
VITEK¿ 2 Gram Positive Susceptibility card (AST-GP67), REF 22226, 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
- 1320165103 10/May/18 1320172103 17/May/18 1320172203 17/May/18 1320179203 24/May/18 1320186103 31/May/18 1320193103 07/Jun/18 1320194103 08/Jun/18 1320215103 29/Jun/18 1320215203 29/Jun/18 1320222103 06/Jul/18 1320223103 07/Jul/18 1320242103 26/Jul/18 1320242203 26/Jul/18 1320249103 02/Aug/18 1320250103 03/Aug/18 1320256103 09/Aug/18 1320256203 09/Aug/18 1320257103 10/Aug/18 1320263103 16/Aug/18 1320264103 17/Aug/18 1320264203 17/Aug/18 1320277103 30/Aug/18 1320277203 30/Aug/18 1320284103 06/Sep/18 1320284203 06/Sep/18 1320285103 07/Sep/18 1320285203 07/Sep/18 1320291103 13/Sep/18 1320291203 13/Sep/18
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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