Recall Z-2134-2021— Cytocell Ltd.
Class II · Terminated
Class II FDA medical device recall by Cytocell Ltd., initiated 2021-05-17, terminated 2022-08-15. Product: CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics. Reason: The device may show unexpected locus specific signals in addition to those at 22q. Users may observe faint additional locus specific signals at 20p12/13..
- Recalling firm
- Cytocell Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-05-17
- Terminated
- 2022-08-15
- Firm location
- Cambridge, N/A, United Kingdom
Product description
CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics
Reason for recall
The device may show unexpected locus specific signals in addition to those at 22q. Users may observe faint additional locus specific signals at 20p12/13.
Data sourced from openFDA. This site is unofficial and independent of the FDA.