Cambridge, N/A, United Kingdom
Cytocell Ltd. recalls
13 recalls recorded since 2018, most recently on 24 May 2023. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls13
Ongoing (FDA)2
Terminated or completed11
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 24 May 2023
- Reason
- DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
- Distribution
- US Nationwide distribution in the states of CA, FL, OH, & SC.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2210-2023, Z-2209-2023
- RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
- RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
Terminated Class II Medical devices
- Recall started
- 27 October 2022
- Terminated
- 27 December 2024
- Reason
- 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.
- Distribution
- TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0341-2023
- CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
Terminated Class II Medical devices
- Recall started
- 27 October 2022
- Terminated
- 27 December 2024
- Reason
- 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
- Distribution
- TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0353-2023
- CytoCell 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:
Terminated Class III Medical devices
- Recall started
- 14 February 2022
- Terminated
- 12 June 2023
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of CT, TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0824-2022
- Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008
Terminated Class III Medical devices
- Recall started
- 4 February 2022
- Terminated
- 6 November 2024
- Reason
- May show unexpected locus specific signals in addition to those at 14q32.
- Distribution
- MN
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0814-2022
- TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A
Terminated Class II Medical devices
- Recall started
- 18 January 2022
- Terminated
- 8 November 2024
- Reason
- 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
- Distribution
- US Nationwide distribution in the states of Hawaii, Missouri, Pennsylvania, Tennessee.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0741-2022
- 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
Terminated Class II Medical devices
- Recall started
- 27 May 2021
- Terminated
- 9 May 2022
- Reason
- May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34
- Distribution
- US Nationwide distribution in the states of CA, IL, KY, NY, OH, TX, UT, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2323-2021
- Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Terminated Class II Medical devices
- Recall started
- 17 May 2021
- Terminated
- 15 August 2022
- Reason
- 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.
- Distribution
- Distribution to US states of CA, IL, MO, NY, PA, TX, and UT, and Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2134-2021
- CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics
Ongoing Class II Medical devices
- Recall started
- 19 March 2021
- Reason
- Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34.
- Distribution
- US Nationwide distribution in the states of TX, OH, NY, IL, CT, AL, IA, MO.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1493-2021
- Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481
Terminated Class II Medical devices
- Recall started
- 22 December 2020
- Terminated
- 7 June 2022
- Reason
- 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.
- Distribution
- Domestic distribution to California, Illinois, Michigan, Minnesota, New Jersey, Texas, and Washington. Foreign distribution to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1099-2021
- Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled in green, consists of two probes (71kb and 131kb) that are situated distal (telomeric) to the CRLF2 gene
Terminated Class II Medical devices
- Recall started
- 17 July 2020
- Terminated
- 30 September 2020
- Reason
- 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.
- Distribution
- Worldwide distribution - US Nationwide distribution and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2829-2020
- 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
Terminated Class III Medical devices
- Recall started
- 26 April 2019
- Terminated
- 16 July 2020
- Reason
- There is an error in the chromomap on the package insert.
- Distribution
- Worldwide Distribution - US Nationwide AL, CO, FL, HI, IA, IL, IN, KY, MA, MD, MI, MO, MS, NC, NJ, NY, TN, TX, UT, WA, and WI. The products were distributed to the following foreign countries: Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1843-2019
- Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D13S319 probe, labelled in red, covers a 156kb region including most of the DLEU2 gene, part of the DLEU1 gene and the D13S319 and D13S272 marke
Terminated Class III Medical devices
- Recall started
- 15 March 2019
- Terminated
- 13 October 2020
- Reason
- There is an error in the chromomap included in the labeling for the product.
- Distribution
- The products were distributed to the following US states: IL, TN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1202-2019
- Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.