Cytocell recalls
6 official recalls and safety alerts involving Cytocell since 2022-03, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Cytocell or the relevant agency.
- 2023-07-26
USCytocell Ltd. recalls RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA…
DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
FDA · DeviceCytocell Ltd.US Nationwide distribution in the states of CA, FL, OH, & SC.Official notice →- 2022-12-07
- US
Cytocell Ltd. recalls CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte specific reagent…
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…
- US
Cytocell Ltd. recalls CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
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.
- 2022-03-30
- US
Cytocell Ltd. recalls Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008
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.
- US
Cytocell Ltd. recalls TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome…
May show unexpected locus specific signals in addition to those at 14q32.
- 2022-03-16
- US
Cytocell Ltd. recalls Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog…
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…
FDA · DeviceCytocell Ltd.US Nationwide distribution in the states of Hawaii, Missouri, Pennsylvania,…Official notice →