—#155254

Product

VITEK 2 Gram Fungal Susceptibility card (AST-YS07), IVD, REF 414967, 20 cards per carton.

FDA product code: N/A
Affected lot / code info: 2870115203 21/Mar/18 2870125203 31/Mar/18 2870129203 04/Apr/18 2870129223 04/Apr/18 2870143203 18/Apr/18 2870150203 25/Apr/18 2870157203 02/May/18 2870209403 23/Jun/18 2870221203 05/JUL/18 2870235203 19/Jul/18 2870241203 25/Jul/18 2870241223 25/Jul/18 2870248403 01/Aug/18 2870276203 29/Aug/18 2870283103 05/Sep/18 2870283203 05/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 #155254. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.