FDA Recall
Open, Classified
Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481
Recall: Z-1493-2021
·
Initiated March 19, 2021
Recall
- Recall Number
- Z-1493-2021
- Event Number
- 87621
- Firm
- Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom
- FEI Number
- 3002646096
- Product Code
- MVU
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- March 19, 2021
Description
Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481
Reason
Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34.
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.
Distribution
US Nationwide distribution in the states of TX, OH, NY, IL, CT, AL, IA, MO.
Quantity
89 probes