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U.S. Department of Health and Human Services

Class 2 Device Recall VITEK 2 AST P646

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  Class 2 Device Recall VITEK 2 AST P646 see related information
Date Initiated by Firm April 20, 2017
Date Posted May 22, 2017
Recall Status1 Terminated 3 on July 22, 2020
Recall Number Z-2503-2017
Recall Event ID 77026
Product Classification unknown device name - Product Code N/A
Product VITEK¿ 2 Gram Positive Susceptibility card (AST-P646), IVD, REF 420144, 20 cards per carton.
Code Information 7460116203 22/Mar/18 7460194203 08/Jun/18 7460236203 20/Jul/18
Recalling Firm/
Manufacturer		 Biomerieux Inc
595 Anglum Rd
Hazelwood MO 63042-2320
For Additional Information Contact Jeff Scanlan
314-731-8694
Manufacturer 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).
FDA Determined
Cause 2		 Packaging
Action 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.
Quantity in Commerce 1,490 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.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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