Z-2342-2017 Class II Terminated

Recalled by Biomerieux Inc — Hazelwood, MO

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
70,261 cartons

Product Description

VITEK 2 Gram-Positive identification card (GP), IVD, REF 21342, 20 cards per carton.

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).

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.

Code Information

2420157103 02/May/18 2420164103 09/May/18 2420169103 14/May/18 2420174203 19/May/18 2420185103 30/May/18 2420198203 12/Jun/18 2420200103 14/Jun/18 2420204103 18/Jun/18 2420205103 19/Jun/18 2420220203 04/Jul/18 2420229203 13/Jul/18 2420239203 23/Jul/18 2420253203 06/Aug/18 2420267103 20/Aug/18 2420290103 12/Sep/18