VITEK¿ 2 Gram Negative Susceptibility card recall: Impurity Out of Spec
VITEK¿ 2 Gram Negative Susceptibility card (AST-GN69), REF 413400, 20 cards per carton.
Why was VITEK¿ 2 Gram Negative Susceptibility card recalled?
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
5890166203 11/May/18 5890175203 20/May/18 5890208103 22/Jun/18 5890229103 13/Jul/18 5890230103 14/Jul/18 5890250203 03/Aug/18 5890251203 04/Aug/18 5890257203 10/Aug/18 5890258203 11/Aug/18 5890259203 12/Aug/18 5890262103 15/Aug/18 5890265203 18/Aug/18 5890270103 23/Aug/18 5890278103 31/Aug/18 5890279103 01/Sep/18 5890286103 08/Sep/18 5890286203 08/Sep/18 5890292103 14/Sep/18
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-GN69), REF 413400, 20 cards per carton.
- Recalling firm
- Biomerieux Inc
- Quantity
- 48,371 cartons
- 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.
- Recall date
- June 21, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)