FDA-Device2023-07-26Class II

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

Cytocell Ltd.
Hazard

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

Sold states
US Nationwide distribution in the states of CA, FL, OH, & SC.
Affected count
61 units
Manufactured in
418 Cambridge Science Park, Milton Road, Oxford Gene Technology, Cambridge, N/A, United Kingdom
Products
RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2210-2023

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