FDAJuly 17, 2020device
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...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
cytocell
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDARET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.2023-05-24
- FDARET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.2023-05-24
- FDACytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte specific reagent probe covering the 14q32.2 locus proximal to the BCL11B gene on chromosome 14. Ref: MPD397812022-10-27
- FDACytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD397822022-10-27
- FDACytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN0082022-02-14
- FDATCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A2022-02-04
- FDADel(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH0242022-01-18
- FDACytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)2021-05-27
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