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[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

recall fda device united-kingdom

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

ProductAssayed Bovine Multi-Sera Level 1, Model No. AL1027
Brand / manufacturerRandox Laboratories, Limited
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2207-2019
Country of noticeUnited Kingdom
Risk levelClass III
Hazard typerecall
Notice date10 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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