Device product
Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481
Z-1493-2021
Product summary
- Firm
- Cytocell Ltd.
- Event
- Event 87621
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 89 probes
- Official record key
device-enforcement:Z-1493-2021
Official wording
Reason: Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34.
Code information: Lot: RD20/253/16, RD21/043/01, RD21/043/02
Distribution pattern: US Nationwide distribution in the states of TX, OH, NY, IL, CT, AL, IA, MO.
Derived failure modes
-
Unknown
Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34.