Recall Z-1493-2021 ยท MVU Reagents, Specific, Analyte
Cytocell Ltd.
Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481
| Date | Mar 19, 2021 |
| Status | Open, Classified |
| Reason | Users 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 |
| 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. |
| Quantity | 89 probes |
| Distribution | US Nationwide distribution in the states of TX, OH, NY, IL, CT, AL, IA, MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.