Device 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.
Z-2829-2020
Product summary
- Firm
- Cytocell Ltd.
- Event
- Event 86084
- Status
- Terminated
- Classification
- Class II
- Quantity
- 62 units
- Official record key
device-enforcement:Z-2829-2020
Official wording
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.
Code information: Lot numbers: 069915, 070433, 069305, 069468
Distribution pattern: Worldwide distribution - US Nationwide distribution and the country of Canada.
Derived failure modes
-
Unknown
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.