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Cytocell Ltd. FDA Recalls
10 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locatingClass IIMay 24, 2023DNAs used during the manufacture of two affected models were |
| RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating aClass IIMay 24, 2023DNAs used during the manufacture of two affected models were |
| CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782Class IIOct 27, 2022An error with the chromomap on version 1 of the package inse |
| CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte spClass IIOct 27, 2022Device is mislabeled. The package insert for this ASR device |
| Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008Class IIIFeb 14, 2022Labelled with an incorrect expiry date on the outer label w |
| TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequencClass IIIFeb 4, 2022May show unexpected locus specific signals in addition to th |
| Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML oClass IIJan 18, 2022individual components have been labelled with incorrect colo |
| Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)Class IIMay 27, 2021May show unexpected locus specific signals in addition to th |
| CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vClass IIMay 17, 2021The device may show unexpected locus specific signals in add |
| Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481Class IIMar 19, 2021Users may observe additional locus specific signals at 9q34. |