VITEK 2 Gram Positive Susceptibility card (AST-GP75), IVD, REF 415670, 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-2469-2017
- Quantity
- 24,158 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
2750173203 18/May/18 2750179103 24/May/18 2750210203 24/Jun/18 2750222103 06/Jul/18 2750236103 20/Jul/18 2750236123 20/Jul/18 2750249103 02/Aug/18 2750277103 30/Aug/18 2750285103 07/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.