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Open, Classified

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

FDA Recall Z-1493-2021 · Posted None

Recalling FirmCytocell Ltd.
Recall StatusOpen, Classified
Product CodeMVU
Date Initiated2021-03-19
Product Quantity89 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.

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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