Cytocell Ltd.: Medical Device Recall in 2021 - (Recall #: Z-2323-2021)

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 LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)

Product Classification:

Class II

Date Initiated: May 27, 2021

Date Posted: August 25, 2021

Recall Number: Z-2323-2021

Event ID: 88294

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

Status: Terminated

Product Quantity: 23 units

Code Information:

Lots 073004 and 072518 (Probe lot 200918-006).

Distribution Pattern:

US Nationwide distribution in the states of CA, IL, KY, NY, OH, TX, UT, VA.

Voluntary or Mandated:

Voluntary: Firm initiated