[Recalled] Assayed Bovine Multi-Sera Level 1, Model No. AL1027 — The firm is re-assigning the Mean of all Instruments target and range for Bile… | FDA 2019-06-10
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | Assayed Bovine Multi-Sera Level 1, Model No. AL1027 |
|---|---|
| Brand / manufacturer | Randox Laboratories, Limited |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2207-2019 |
| Country of notice | United Kingdom |
| Risk level | Class III |
| Hazard type | recall |
| Notice date | 10 June 2019 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL.
This Class III 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 →
Related recalls from Randox Laboratories, Limited
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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