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U.S. Department of Health and Human Services

Class 2 Device Recall VITEK 2 AST GN49

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  Class 2 Device Recall VITEK 2 AST GN49 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-2380-2017
Recall Event ID 77026
Product Classification System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
Product VITEK¿ 2 Gram Negative Susceptibility card (AST-GN49), REF 412091, 20 cards per carton.
Code Information 4690028203 24/Dec/17 4690167103 12/May/18 4690168103 13/May/18 4690187103 01/Jun/18 4690197203 11/Jun/18 4690208103 22/Jun/18 4690224203 08/Jul/18 4690229103 13/Jul/18 4690230103 14/Jul/18 4690237103 21/Jul/18 4690254203 07/Aug/18 4690265203 18/Aug/18 4690272103 25/Aug/18 4690277203 30/Aug/18 4690287203 09/Sep/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 32,628 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.
Total Product Life Cycle TPLC Device Report
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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