—#155097

Product

VITEK 2 Gram Negative Susceptibility card (AST-GN49), REF 412091, 20 cards per carton.

FDA product code: LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device class: Class 2
Medical specialty: Microbiology
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Packaging

Action the firm took

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.

Recalling firm

Firm: Biomerieux Inc
Address: 595 Anglum Rd, Hazelwood, Missouri 63042-2320

Distribution

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.

Timeline

Recall initiated: 2017-04-20
Posted by FDA: 2017-05-22
Terminated: 2020-07-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #155097. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.