RecallDepth

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

Company
Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom
Recall Initiated
March 19, 2021
Recall Number
Z-1493-2021
Quantity
89 probes

Reason for Recall

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

Distribution

US Nationwide distribution in the states of TX, OH, NY, IL, CT, AL, IA, MO.

Lot / Code Info

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

Root Cause

Under Investigation by firm

Action Taken

On 3/19/2021, Cytocell issued an Urgent Medical Device Recall notice via email notifying customers they may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34.

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