[Recalled] VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670 — As the temperature and time out of range was exceeded, product performances can… | FDA 2022-11-09
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670 |
|---|---|
| Brand / manufacturer | Biomerieux Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0843-2023 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 09 November 2022 |
| EAN / barcode | 03573026437183 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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.
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