Cytocell Ltd.: Medical Device Recall in 2023 - (Recall #: Z-2209-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.
Product Description:

RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.

Product Classification:

Class II

Date Initiated: May 24, 2023
Date Posted: July 26, 2023
Recall Number: Z-2209-2023
Event ID: 92586
Reason for Recall:

DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.

Status: Ongoing
Product Quantity: 60 units
Code Information:

Catalog No. LPS508-A; UDI-DI: 05055844900509; Lot No. 076763, 077253, 080125, 080763, 082128, 083041, 083246, 083555.

Distribution Pattern:

US Nationwide distribution in the states of CA, FL, OH, & SC.

Voluntary or Mandated:

Voluntary: Firm initiated