Recall Z-2209-2023— Cytocell Ltd.
Class II · Ongoing
Class II FDA medical device recall by Cytocell Ltd., initiated 2023-05-24. 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: 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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.