Cytocell Ltd.: Medical Device Recall in 2023 - (Recall #: Z-2210-2023)

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 Distal 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-2210-2023

Event ID: 92586

Reason for Recall:

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

Status: Ongoing

Product Quantity: 61 units

Code Information:

Catalog No. LPS509-A; UDI-DI: 05055844900516; Lot No. 076764, 080124, 082129, 082560, 083247, 083550, 083850.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated