[Recalled] Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent — Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have fai… | FDA 2020-07-10
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent |
|---|---|
| Brand / manufacturer | RANDOX LABORATORIES, LTD. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2923-2020 |
| Country of notice | United Kingdom |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 10 July 2020 |
| EAN / barcode | 05055273200607 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performance claims prior to expiry on 28th Sept 2020.
This Class II recall concerns device products distributed in United Kingdom 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 →
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.