FDAClass IIMay 5, 2021

Chromosome X Alpha-Satellite in FITC Spectrum - Product recall

Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481

Why was Chromosome X Alpha-Satellite in FITC Spectrum - Product recalled?

Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: RD20/253/16, RD21/043/01, RD21/043/02

Product
Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481
Recalling firm
Cytocell Ltd.
Quantity
89 probes
Distribution
US Nationwide distribution in the states of TX, OH, NY, IL, CT, AL, IA, MO.
Recall date
May 5, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls