Z-2464-2017 Class II Terminated
FDA device recall Z-2464-2017 was initiated by Biomerieux Inc on April 20, 2017 and is designated Class II. 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). The recall status is terminated (terminated July 22, 2020). Affected quantity: 1,592 cartons.
Recall Details
- Product Type
- Devices
- Report Date
- June 21, 2017
- Initiation Date
- April 20, 2017
- Termination Date
- July 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,592 cartons
Product Description
Reason for Recall
Distribution Pattern
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.