medical Class II Updated 2021-08-04

Cytocell Ltd. recalls CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Prob

Recalled Product

CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics

Hazard / Issue

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.

Issued by

FDA

Affected States: CA, IL, MO, NY, PA, TX, UT
Lot/Code Info: Lot Numbers: 071399 072985
View official government recall

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