Recall Z-2210-2023— Cytocell Ltd.

Class II · Ongoing

Class II FDA medical device recall by Cytocell Ltd., initiated 2023-05-24. Product: RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.. Reason: DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing..

Recalling firm
Cytocell Ltd.
Classification
Class II
Status
Ongoing
Initiated
2023-05-24
Firm location
Cambridge, N/A, United Kingdom

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.