Cytocell Ltd.: Medical Device Recall in 2021 - (Recall #: Z-2134-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 17, 2021

Date Posted: August 4, 2021

Recall Number: Z-2134-2021

Event ID: 88138

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.

Status: Terminated

Product Quantity: 50

Code Information:

Lot Numbers: 071399 072985

Distribution Pattern:

Distribution to US states of CA, IL, MO, NY, PA, TX, and UT, and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated