Recall Z-2378-2017
Biomerieux Inc · initiated April 20, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VITEK 2 Gram Fungal Susceptibility card (AST-YS05), REF 411945, 20 cards per carton.
Codes / lots: 2850108203 14/Mar/18 2850209403 23/Jun/18
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: Packaging
Action taken
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.
Details
- Recall number
- Z-2378-2017
- Initiated
- April 20, 2017
- Posted by FDA
- May 22, 2017
- Terminated
- July 22, 2020
- Product code
- NGZ – Susceptibility Test Plate, Antifungal
- Quantity
- 2251 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…
- Recalling firm
- Biomerieux Inc, Hazelwood, MO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2341-2017 Class II | VITEK 2 Gram-Negative identification card (GN), IVD, REF 21341, 20 cards per carton.The integrity of the product container may be compromised thereby exposing product to moisture which could… | 04/20/2017Terminated |
| Z-2342-2017 Class II | VITEK 2 Gram-Positive identification card (GP), IVD, REF 21342, 20 cards per carton.The integrity of the product container may be compromised thereby exposing product to moisture which could… | 04/20/2017Terminated |
| Z-2343-2017 Class II | VITEK 2 Yeast identification card (YST), IVD, REF 21343, 20 cards per carton. .The integrity of the product container may be compromised thereby exposing product to moisture which could… | 04/20/2017Terminated |
| Z-2344-2017 Class II | VITEK 2 Bacillus identification card (BCL), IVD, REF 21345, 20 cards per carton.The integrity of the product container may be compromised thereby exposing product to moisture which could… | 04/20/2017Terminated |
| Z-2345-2017 Class II | VITEK 2 Neisseria-Haemophilus identification card (NH), IVD, REF 21346, 20 cards per…The integrity of the product container may be compromised thereby exposing product to moisture which could… | 04/20/2017Terminated |
| Z-2346-2017 Class II | VITEK 2 Anaerobic and Corynebacteria identification card (ANC), REF 21347, 20 cards per…The integrity of the product container may be compromised thereby exposing product to moisture which could… | 04/20/2017Terminated |
| Z-2347-2017 Class II | VITEK 2 Gram Negative Susceptibility card (AST-GN09), REF 22008, 20 cards per carton.The integrity of the product container may be compromised thereby exposing product to moisture which could… | 04/20/2017Terminated |
| Z-2348-2017 Class II | VITEK 2 Gram Negative Susceptibility card (AST-GN13), REF 22095, 20 cards per carton.The integrity of the product container may be compromised thereby exposing product to moisture which could… | 04/20/2017Terminated |
| Z-2349-2017 Class II | VITEK 2 Gram Negative Susceptibility card (AST-GN14), REF 22096, 20 cards per carton.The integrity of the product container may be compromised thereby exposing product to moisture which could… | 04/20/2017Terminated |
| Z-2350-2017 Class II | VITEK 2 Fungal Susceptibility card (AST-YS01), REF 22108, 20 cards per carton.The integrity of the product container may be compromised thereby exposing product to moisture which could… | 04/20/2017Terminated |
| Z-2351-2017 Class II | VITEK 2 Gram Negative Susceptibility card (AST-GN16), REF 22139, 20 cards per carton.The integrity of the product container may be compromised thereby exposing product to moisture which could… | 04/20/2017Terminated |
| Z-2352-2017 Class II | VITEK 2 Gram Positive Susceptibility card (AST-P577), REF 22218, 20 cards per carton.The integrity of the product container may be compromised thereby exposing product to moisture which could… | 04/20/2017Terminated |
| Z-2353-2017 Class II | VITEK 2 Gram Positive Susceptibility card (AST-GP67), REF 22226, 20 cards per carton.The integrity of the product container may be compromised thereby exposing product to moisture which could… | 04/20/2017Terminated |
| Z-2354-2017 Class II | VITEK 2 Gram Positive Susceptibility card (AST-GP68), REF 22231, 20 cards per carton.The integrity of the product container may be compromised thereby exposing product to moisture which could… | 04/20/2017Terminated |
| Z-2355-2017 Class II | VITEK 2 Gram Positive Susceptibility card (AST-P580), REF 22233, 20 cards per carton.The integrity of the product container may be compromised thereby exposing product to moisture which could… | 04/20/2017Terminated |
| Z-2356-2017 Class II | VITEK 2 Gram Positive Susceptibility card (AST-P584), REF 22252, 20 cards per carton.The integrity of the product container may be compromised thereby exposing product to moisture which could… | 04/20/2017Terminated |
| Z-2357-2017 Class II | VITEK 2 Gram Negative Susceptibility card (AST-N102), REF 22258, 20 cards per carton.The integrity of the product container may be compromised thereby exposing product to moisture which could… | 04/20/2017Terminated |
| Z-2358-2017 Class II | VITEK 2 Gram Positive Susceptibility card (AST-P586), REF 22276, 20 cards per carton.The integrity of the product container may be compromised thereby exposing product to moisture which could… | 04/20/2017Terminated |
| Z-2359-2017 Class II | VITEK 2 Gram Positive Susceptibility card (AST-P592), REF 22287, 20 cards per carton.The integrity of the product container may be compromised thereby exposing product to moisture which could… | 04/20/2017Terminated |
| Z-2360-2017 Class II | VITEK 2 Gram Positive Susceptibility card (AST-P597), REF 22298, 20 cards per carton.The integrity of the product container may be compromised thereby exposing product to moisture which could… | 04/20/2017Terminated |
| Z-2361-2017 Class II | VITEK 2 Gram Positive Susceptibility card (AST-GP69), REF 22304, 20 cards per carton.The integrity of the product container may be compromised thereby exposing product to moisture which could… | 04/20/2017Terminated |
| Z-2362-2017 Class II | VITEK 2 Gram Positive Susceptibility card (AST-P600), REF 22313, 20 cards per carton.The integrity of the product container may be compromised thereby exposing product to moisture which could… | 04/20/2017Terminated |
| Z-2363-2017 Class II | VITEK 2 Gram Positive Susceptibility card (AST-P603), REF 22320, 20 cards per carton.The integrity of the product container may be compromised thereby exposing product to moisture which could… | 04/20/2017Terminated |
| Z-2364-2017 Class II | VITEK 2 Gram Positive Susceptibility card (AST-P605), REF 22325 20 cards per carton.The integrity of the product container may be compromised thereby exposing product to moisture which could… | 04/20/2017Terminated |
| Z-2365-2017 Class II | VITEK 2 Gram Positive Susceptibility card (AST-P606), REF 22330, 20 cards per carton.The integrity of the product container may be compromised thereby exposing product to moisture which could… | 04/20/2017Terminated |
| Z-2366-2017 Class II | VITEK 2 Gram Negative Susceptibility card (AST-GN38), REF 22331, 20 cards per carton.The integrity of the product container may be compromised thereby exposing product to moisture which could… | 04/20/2017Terminated |
| Z-2367-2017 Class II | VITEK 2 Gram Positive Susceptibility card (AST-P607), REF 22335, 20 cards per carton.The integrity of the product container may be compromised thereby exposing product to moisture which could… | 04/20/2017Terminated |
| Z-2368-2017 Class II | VITEK 2 Gram Positive Susceptibility card (AST-P608), REF 22336, 20 cards per carton.The integrity of the product container may be compromised thereby exposing product to moisture which could… | 04/20/2017Terminated |
| Z-2369-2017 Class II | VITEK 2 Gram Positive Susceptibility card (AST-P612), REF 22359, 20 cards per carton.The integrity of the product container may be compromised thereby exposing product to moisture which could… | 04/20/2017Terminated |
| Z-2370-2017 Class II | VITEK 2 Gram Negative Susceptibility card (AST-XN01), REF 410025, 20 cards per carton.The integrity of the product container may be compromised thereby exposing product to moisture which could… | 04/20/2017Terminated |