Cytocell Ltd. recalls
Every recall we track for Cytocell Ltd. — 14 in all, from 2019–2023 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Cytocell Ltd. peaked in 2022 (5); 14 since 2017.
All FDA recall records for Cytocell Ltd. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 2 | 0 | 2 |
| 2020 | 0 | 0 | 2 | 0 | 2 |
| 2021 | 0 | 0 | 3 | 0 | 3 |
| 2022 | 0 | 0 | 5 | 0 | 5 |
| 2023 | 0 | 0 | 2 | 0 | 2 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Cytocell Ltd. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Cytocell Ltd. recalls
13 shown- Lower riskMedical device
Cytocell Ltd. recalls RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating
Cytocell recalls RET Distal Probes used in lab DNA testing due to accidental DNA inversion during manufacturing. Affected models have specific catalog and lot numbers.
CytocellMay 24, 2023 - Lower riskMedical device
Cytocell Ltd. recalls CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte
Cytocell recalls a T-cell malignancy test probe due to incorrect chromomap in package inserts. This may affect lab results but does not pose immediate safety risks.
Cytoc: a company name from the titleOct 27, 2022 - Lower riskMedical device
Cytocell Ltd. recalls CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
Cytocell recalls BCL11B Distal in Texas Red Spectrum reagent due to incorrect chromomap coordinates in version 1 package inserts. Affected units may have inaccurate nucleotide locations.
CytocellOct 27, 2022 - Lower riskMedical device
Cytocell Ltd. recalls Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008
Cytocell recalls 8 Square Template Slides with incorrect expiry date labels. The correct expiry is February 2022, not May 2023 as shown. Affected items may expire prematurely.
CytocellFeb 14, 2022 - Lower riskMedical device
Cytocell Ltd. recalls TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA
Cytocell recalls TCL1 Breakapart Probe for possible unexpected DNA signals. Learn if you have the affected product and what to do.
Cytoc:ellFeb 4, 2022 - Lower riskMedical device
Cytocell Ltd. recalls Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML
Cytocell recalls Del(5q) FISH Probe Kit for incorrect color labeling that could lead to wrong results in AML/MDS chromosome testing. Affected kits have red and green probes swapped.
Cytoc:ellJan 18, 2022 - Lower riskMedical device
Cytocell Ltd. recalls Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Cytocell recalls specific lab reagents that may show unexpected signals in genetic tests. Affected lots: 073004 and 072518 (Probe lot 200918-006).
CytocellMay 27, 2021 - Lower riskMedical device
Cytocell Ltd. recalls CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in
Cytocell recalls DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe (Model LPU004-A) due to potential for unexpected genetic signals in testing. Affected lots: 071399, 072985.
CytocellMay 17, 2021 - Lower riskMedical device
Cytocell Ltd. recalls Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481
Cytocell recalls Chromosome X Alpha-Satellite in FITC Spectrum reagents (model MPA3481) due to possible false signals at 9q3: users may see extra locus-specific signals despite no cross-reactivity claims.
CytocellMar 19, 2021 - Lower riskMedical device
Cytocell Ltd. recalls Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled in green, consists of
Cytocell recalls Aquarius LPH 511-A CRLF2 Distal Probe Green due to potential false lab test results. This may cause normal samples to be incorrectly reported as abnormal in certain tests.
CytocellDec 22, 2020 - Lower riskMedical device
Cytocell Ltd. recalls Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a
Cytocell recalls LPH533-A NUP98 Distal Probe Green due to potential false positive results with certain lab tests. This low-risk issue affects specific lot numbers.
CytocellJul 17, 2020 - Lower riskMedical device
Cytocell Ltd. recalls Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D13S319 probe, labelled in red, covers a 156kb
Cytocell recalls Aquarius D13S319 Plus Deletion Probe (Model LPH068-A) due to an error in the chromomap on the package insert. Affected units include specific lot numbers.
CytocellApr 26, 2019 - Lower riskMedical device
Cytocell Ltd. recalls Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.
Cytocell recalls Aquarius CSF1R/RPS14 Probe Red reagent (model LPH540-A) with lot numbers 056996, 061156, 062616, 062808 due to a labeling error in the chromomap.
Cytoc:ellMar 15, 2019
Cytocell Ltd. recall questions
How many recalls has Cytocell Ltd. had?
14 recalls from Cytocell Ltd. are on record with U.S. safety agencies, from 2019–2023.
What is the most recent Cytocell Ltd. recall?
Cytocell Ltd. recalls RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating, dated May 24, 2023. Every Cytocell Ltd. recall is listed on this page, newest first.
What should I do if I have a recalled Cytocell Ltd. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Cytocell Ltd. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.