Cytocell Ltd. recalls Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
- Recall date
- May 27, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2323-2021
- FDA classification
- Class II
- Brand / firm
- Cytocell Ltd.
- Sold / distributed
- US Nationwide distribution in the states of CA, IL, KY, NY, OH, TX, UT, VA.
Why it was recalled
May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
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