Recall Z-2323-2021— Cytocell Ltd.
Class II · Terminated
Class II FDA medical device recall by Cytocell Ltd., initiated 2021-05-27, terminated 2022-05-09. Product: Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's). Reason: May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34.
- Recalling firm
- Cytocell Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-05-27
- Terminated
- 2022-05-09
- Firm location
- Cambridge, N/A, United Kingdom
Product description
Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Reason for recall
May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34
Data sourced from openFDA. This site is unofficial and independent of the FDA.