Manufacturer

Cytocell Ltd.

14 recalls in our database name Cytocell Ltd. as the manufacturing or recalling firm.

What the numbers show

Total: 14
Critical: 0
Severe: 0
Most recent: 2023-07-26

Of the 14 recalls from Cytocell Ltd. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–14 of 14

HighFDA (Devices)·Z-2210-2023·2023-07-26
RET Distal Probe Recalled Due to Manufacturing Defect in DNA Sequences
FDA recalls RET Distal Probe due to manufacturing defect where DNA sequences used in production were inverted. The defect affects 61 units distributed in California, Florida, Ohio, and South Carolina and may impact diagnostic accuracy.
Product
RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2209-2023·2023-07-26
FDA Recalls RET Proximal Probe Laboratory Diagnostic Kits for Inverted DNA
Cytocell Ltd. RET Proximal Probe kits distributed to laboratories in California, Florida, Ohio, and South Carolina are being recalled due to inverted DNA sequences introduced during manufacturing.
Product
RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0353-2023·2022-12-07
Laboratory Diagnostic Probe Recalled for Incorrect Chromosome Map Labeling
Cytocell Ltd. recalls CytoCell BCL11B Proximal probe used in T-cell malignancy testing (lot RD22/230/10). The package insert contains an incorrect chromosome map that doesn't match the probe design.
Product
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: MPD39781
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0341-2023·2022-12-07
BCL11B Diagnostic Reagent Recalled for Chromomap Documentation Error
Cytocell Ltd. is recalling a diagnostic reagent due to an error in the chromomap on the package insert. The nucleotide locations in the text are correct, but the chromosome map was created using incorrect coordinates.
Product
CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0824-2022·2022-03-30
Cytocell Microscope Slides Recall: Incorrect Expiry Date on Label
Cytocell Ltd. is recalling Cytocell 8 Square Template Slides because the outer label displays an incorrect expiration date of 2023-05 when the actual validated shelf life expires 2022-02.
Product
Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0814-2022·2022-03-30
TCL1 Breakapart Probe May Display Unexpected Genetic Signals
Cytocell Ltd. is recalling TCL1 Breakapart FISH probes (Lot 074612) because the diagnostic test may show unexpected signals beyond the intended chromosome target.
Product
TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0741-2022·2022-03-16
FISH Diagnostic Probe Kit Color Labeling Error Affects Test Results
Cytocell Ltd. is recalling a Del(5q) Deletion FISH Probe Kit due to incorrect color labeling on probe components. The mislabeling may cause misinterpretation of test results for patients with AML or MDS.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2323-2021·2021-08-25
Cytocell DNA Diagnostic Probe Recalled for Unexpected Chromosomal Signals
Cytocell Ltd. is recalling a DNA diagnostic probe that may produce unexpected signals at additional chromosomal locations during testing. The affected probe is an in vitro diagnostic reagent used in laboratory cytogenetic analysis.
Product
Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2134-2021·2021-08-04
Diagnostic Genetic Probe Recalled for Unexpected Chromosome Signals
Cytocell Ltd. is recalling CytoCell DiGeorge/VCFS genetic probes that may display unexpected chromosome signals, potentially causing misdiagnosis. Affected reagents were distributed to laboratories in multiple US states and Canada.
Product
CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-1493-2021·2021-05-05
Cytocell Recalls Chromosome X Alpha-Satellite Probes Due to Cross-Reactivity
Cytocell Ltd. is recalling 89 Chromosome X Alpha-Satellite probes because users may observe additional signals at 9q34, contradicting the insert.
Product
Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1099-2021·2021-02-17
Cytocell Recalls Aquarius CRLF2 Distal Probe Due to Faint Signal Risk
Cytocell Ltd. is recalling 72 units of the Aquarius LPH 511-A CRLF2 Distal Probe Green because faint additional signals may cause normal samples to be misreported as abnormal.
Product
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
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-2829-2020·2020-08-26
Cytocell NUP98 Distal Probe Green Recalled for False Positive Risk
Cytocell Ltd. is recalling NUP98 Distal Probe Green units due to a low risk of false positive results in laboratory testing.
Product
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 situ hybridisation (FISH) is a technique that allows the vis
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1843-2019·2019-06-26
Cytocell Aquarius D13S319 Probe Recalled for Package Insert Error
Cytocell Ltd. is recalling Aquarius D13S319 Plus Deletion Probes because the chromomap on the package insert contains an error.
Product
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 markers. The 13qter subtelomere specific probe, labelled in green
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1202-2019·2019-05-01
Cytocell Recalls Aquarius CSF1R/RPS14 Probe Due to Labeling Error
Cytocell Ltd. is recalling 19 units of the Aquarius CSF1R/RPS14 Probe Red due to an error in the chromomap labeling.
Product
Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.
Category
Medical Device
Distribution
2 states