Medical device recalls Moderate risk

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)

Get recall alerts

Free email alert whenever Cytocell Ltd. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Cytocell Ltd.