FDA recall Z-2209-2023

Cytocell Ltd. · Class II · device

Product

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

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2023-05-24
Report date
2023-07-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cambridge, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2209-2023