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[Recalled] Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's) — May show unexpected locus specific signals in addition to those at 19p13.3 | FDA 2021-05-27

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

ProductCytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Brand / manufacturerCytocell Ltd.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2323-2021
Country of noticeUnited Kingdom
Risk levelClass II
Hazard typerecall
Notice date27 May 2021

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34

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 Cytocell Ltd.

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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