VITEK 2 Gram Negative Susceptibility card (AST-GN49), REF 412091, 20 cards per carton.
This recall has been terminated (originally issued May 22, 2017).
- Company
- Biomerieux Inc
- Recall Initiated
- April 20, 2017
- Posted
- May 22, 2017
- Terminated
- July 22, 2020
- Recall Number
- Z-2380-2017
- Quantity
- 32,628 cartons
- Firm Location
- Hazelwood, MO
- Official Source
- View on FDA website ↗
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).
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.
Lot / Code Info
4690028203 24/Dec/17 4690167103 12/May/18 4690168103 13/May/18 4690187103 01/Jun/18 4690197203 11/Jun/18 4690208103 22/Jun/18 4690224203 08/Jul/18 4690229103 13/Jul/18 4690230103 14/Jul/18 4690237103 21/Jul/18 4690254203 07/Aug/18 4690265203 18/Aug/18 4690272103 25/Aug/18 4690277203 30/Aug/18 4690287203 09/Sep/18
Root Cause
Packaging
Action Taken
The firm posted their recall notification on their customer website on 4/20/2017. The firm sent the recall notification letter to their customers via FedEx on 4/21/2017 for delivery 4/24/2017. A follow-up recall notice will be issued on 5/08/2017 which identified 3 additional lots impacted by the recall.