[Recalled] VITEK¿ 2 Gram Negative Susceptibility card (AST-N202), REF 412863, 20 cards per carton. — The integrity of the product container may be compromised thereby exposing prod… | FDA 2017-04-20
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | VITEK¿ 2 Gram Negative Susceptibility card (AST-N202), REF 412863, 20 cards per carton. |
|---|---|
| Brand / manufacturer | Biomerieux Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2388-2017 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 20 April 2017 |
| EAN / barcode | 572381520 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Biomerieux Inc
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.