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Recall Observatory FDA recall evidence

Device product

VITEK¿ 2 Gram Negative Susceptibility card (AST-GN69), REF 413400, 20 cards per carton.

Z-2418-2017

April 20, 2017

Class II

Product summary

Firm
Biomerieux Inc
Event
Event 77026
Status
Terminated
Classification
Class II
Quantity
48,371 cartons
Official record key
device-enforcement:Z-2418-2017

Official wording

Reason: The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

Code information: 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

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.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    loss of potency