FDAJanuary 18, 2022device
Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH024
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
individual components have been labelled with incorrect colours. The red and green colours are opposite to those specified in the product labelling. The EGR1 probe is labelled in green rather than red and the control probe labelled in red rather than green. The expected positive signal pattern in the case of 1x deleted 5q will be 1G2R instead of 1R2G, an incorrect result
What to do
FDA enforcement status: Terminated
Brands named
cytocell
UPCs
05055844901551
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- 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
- 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
- FDACytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD397822022-10-27
- 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 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
- FDACytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)2021-05-27
- FDACytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics2021-05-17
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