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[Recalled] Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy.

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

ProductHuman Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy.
Brand / manufacturerRandox Laboratories, Limited
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2150-2019
Country of noticeUnited Kingdom
Risk levelClass II
Hazard typerecall
Notice date11 June 2019

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT has been incorrectly assigned in specific lots of the Human Assayed Multi-Sera Controls.

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 →

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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