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[Recalled] Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label is UTAK LABORATORIES, INC., Valencia, CA. Control for in vitro diagnostics. — The product has an incorrect reference value for cadmium and

recall fda device united-states

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

Recall details

ProductUtak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label is UTAK LABORATORIES, INC., Valencia, CA. Control for in vitro diagnostics.
Brand / manufacturerUtak Laboratories Inc
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2407-2020
Country of noticeUnited States
Risk levelClass III
Hazard typerecall
Notice date20 March 2020

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: The product has an incorrect reference value for cadmium and an incorrect expected range.

This Class III 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 →

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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