Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481
This recall is currently active, issued March 19, 2021. It was issued by 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
- Official Source
- View on FDA website ↗
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.