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[Recalled] Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481 — Users may observe additional locus specific signals at 9q34 | FDA 2021-03-19

recall fda device united-kingdom

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductChromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481
Brand / manufacturerCytocell Ltd.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-1493-2021
Country of noticeUnited Kingdom
Risk levelClass II
Hazard typerecall
Notice date19 March 2021

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 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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