[Recalled] VITEK¿ 2 Gram Positive Susceptibility card (AST-P619), REF 411944, 20 cards per carton. — The integrity of the product container may be compromised thereby exposing prod… | FDA 2017-04-20
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | VITEK¿ 2 Gram Positive Susceptibility card (AST-P619), REF 411944, 20 cards per carton. |
|---|---|
| Brand / manufacturer | Biomerieux Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2377-2017 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 20 April 2017 |
| EAN / barcode | 4990237103 |
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.