Recall Z-2829-2020— Cytocell Ltd.
Class II · Terminated
Class II FDA medical device recall by Cytocell Ltd., initiated 2020-07-17, terminated 2020-09-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151kb probe distal to the NUP98 gene, covering the ZNF195 gene and the D11S4731 marker. Fluorescence in situ hybridisation (FISH) is a technique that allows the visualisation of DNA sequences upon chromosomes.. Reason: A low risk of a false positive result being issued with a laboratory developed test (LDT) that utilizes the LPH533-A NUP98 Distal Probe Green..
- Recalling firm
- Cytocell Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-07-17
- Terminated
- 2020-09-30
- Firm location
- Cambridge, N/A, United Kingdom
Product description
Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151kb probe distal to the NUP98 gene, covering the ZNF195 gene and the D11S4731 marker. Fluorescence in situ hybridisation (FISH) is a technique that allows the visualisation of DNA sequences upon chromosomes.
Reason for recall
A low risk of a false positive result being issued with a laboratory developed test (LDT) that utilizes the LPH533-A NUP98 Distal Probe Green.
Data sourced from openFDA. This site is unofficial and independent of the FDA.