Recall Z-1493-2021— Cytocell Ltd.
Class II · Ongoing
Class II FDA medical device recall by Cytocell Ltd., initiated 2021-03-19. Product: 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..
- Recalling firm
- Cytocell Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-03-19
- Firm location
- Cambridge, N/A, United Kingdom
Product description
Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.