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[Recalled] Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is intended for in vitro diagnostic (IVD) use. SOX-10 Rabbit Polyclonal Primary Antibody is intended for laboratory use in the detection of the SOX-10 protein

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

ProductCell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is intended for in vitro diagnostic (IVD) use. SOX-10 Rabbit Polyclonal Primary Antibody is intended for laboratory use in the detection of the SOX-10 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative imm
Brand / manufacturerLeica Biosystems Richmond Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-3126-2017
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date14 July 2017

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.

This Class II 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 →

Related recalls from Leica Biosystems Richmond Inc.

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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