Cytocell Recalls
14 recalls on record · May 1, 2019 to July 26, 2023 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 26, 2023Medical DevicesFDA
Cytocell Ltd. recalls RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a
Hazard: DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
July 26, 2023Medical DevicesFDA
Cytocell Ltd. recalls RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating
Hazard: DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
December 7, 2022Medical DevicesFDA
Cytocell Ltd. recalls CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte sp
Hazard: Device is mislabeled. The package insert for this ASR device contains a chromomap - an image showing the position the FISH probe maps to on the specific chromosome. For this device the chromomap in version 1 of the package insert is incorrect and doesn't not match the probe design or specification contained on the package insert
December 7, 2022Medical DevicesFDA
Cytocell Ltd. recalls CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
Hazard: An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide locations specified in the insert are correct but the map has been created using the wrong coordinates.
March 30, 2022Medical DevicesFDA
Cytocell Ltd. recalls Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008
Hazard: Labelled with an incorrect expiry date on the outer label with an extended expiry date than the validated shelf life. The correct expiry date for the device is 2022-02 and not 2023-05 as shown on the outer label.
March 30, 2022Medical DevicesFDA
Cytocell Ltd. recalls TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequenc
Hazard: May show unexpected locus specific signals in addition to those at 14q32.
March 16, 2022Medical DevicesFDA
Cytocell Ltd. recalls Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML o
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
August 25, 2021Medical DevicesFDA
Cytocell Ltd. recalls Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Hazard: May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34
August 4, 2021Medical DevicesFDA
Cytocell Ltd. recalls CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in v
Hazard: The device may show unexpected locus specific signals in addition to those at 22q. Users may observe faint additional locus specific signals at 20p12/13.
May 5, 2021Medical DevicesFDA
Cytocell Ltd. recalls Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481
Hazard: Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34.
February 17, 2021Medical DevicesFDA
Cytocell Ltd. recalls Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled in green, consists
Hazard: Users may observe very faint additional locus specific signals at 11q13. There is a low risk of a normal sample being reported as not normal in a resulting laboratory developed test (LDT) that utilizes the LPH511-A CRLF2 Distal Probe Green.
August 26, 2020Medical DevicesFDA
Cytocell Ltd. recalls Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151k
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.
June 26, 2019Medical DevicesFDA
Cytocell Ltd. recalls Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D13S319 probe, labelled in red, covers a 156
Hazard: There is an error in the chromomap on the package insert.
May 1, 2019Medical DevicesFDA
Cytocell Ltd. recalls Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.
Hazard: There is an error in the chromomap included in the labeling for the product.