VITEK¿ 2 Gram Streptococcus Susceptibility card recall: Impurity Out of Spec
VITEK¿ 2 Gram Streptococcus Susceptibility card (AST-ST01), REF 410028, 20 cards per carton.
Why was VITEK¿ 2 Gram Streptococcus 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?
5400115203 21/Mar/18 5400122223 28/Mar/18 5400136203 11/Apr/18 5400136223 11/Apr/18 5400136243 11/Apr/18 5400143203 18/Apr/18 5400192203 06/Jun/18 5400192223 06/Jun/18 5400192243 06/Jun/18 5400199203 13/Jun/18 5400216203 30/Jun/18 5400221203 05/Jul/18 5400238203 22/Jul/18 5400238223 22/Jul/18 5400238243 22/Jul/18 5400262223 15/Aug/18 5400269203 22/Aug/18 5400276203 29/Aug/18 5400276213 29/Aug/18 5400283203 05/Sep/18 5400283213 05/Sep/18
- Product
- VITEK¿ 2 Gram Streptococcus Susceptibility card (AST-ST01), REF 410028, 20 cards per carton.
- Recalling firm
- Biomerieux Inc
- Quantity
- 19,398 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)