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Cytocell Ltd.

Complete recall history across all FDA and CPSC categories — 14 total recalls

Cytocell Ltd. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (14)

FDA medical device enforcement actions by Cytocell Ltd.

Date Product Reason Class
May 24, 2023 RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a labo... DNAs used during the manufacture of two affected models were accidentally inv... Class II
May 24, 2023 RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a labora... DNAs used during the manufacture of two affected models were accidentally inv... Class II
Oct 27, 2022 CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell relate... Device is mislabeled. The package insert for this ASR device contains a chrom... Class II
Oct 27, 2022 CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: ... An error with the chromomap on version 1 of the package insert which is incor... Class II
Feb 14, 2022 Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008 Labelled with an incorrect expiry date on the outer label with an extended e... Class III
Feb 4, 2022 TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a techniq... May show unexpected locus specific signals in addition to those at 14q32. Class III
Jan 18, 2022 Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in c... individual components have been labelled with incorrect colours. The red and ... Class II
May 27, 2021 Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte sp... May show unexpected locus specific signals in addition to those at 19p13.3. U... Class II
May 17, 2021 CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number L... The device may show unexpected locus specific signals in addition to those at... Class II
Mar 19, 2021 Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specif... Users may observe additional locus specific signals at 9q34. The device pack ... Class II
Dec 22, 2020 Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2... Users may observe very faint additional locus specific signals at 11q13. Ther... Class II
Jul 17, 2020 Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal p... A low risk of a false positive result being issued with a laboratory develope... Class II
Apr 26, 2019 Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D... There is an error in the chromomap on the package insert. Class III
Mar 15, 2019 Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific re... There is an error in the chromomap included in the labeling for the product. Class III

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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