Lower riskMedical device recall · FDA · Published January 18, 2022
Cytocell Del(5q) FISH Probe Kit: Incorrect Color Labels May Cause Wrong Results
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.
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
Take action
Contact the company
📍Recalling firmCytocell Ltd.418 Cambridge Science Park, Milton Road, Oxford Gene Technology · Cambridge, United Kingdom
“Cytocell Del(5q) FISH Probe Kit: Incorrect Color Labels May Cause Wrong Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61254-cytocell-del-5q-fish-probe-kit-incorrect-color-labels-may. Based on FDA recall #Z-0741-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0741-2022%22&limit=1).
Cytocell Ltd. recalled the Del(5q) Deletion FISH Probe Kit on Jan. 18, 2022, after the FDA announced that incorrect color labeling could lead to false results for patients with AML or MDS. The Food and Drug Administration issued the voluntary Class II recall.
How to tell if you have it
Brand: Cytocell
Product: Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML
Catalog Number: USA-LPH024
Lot Number: 075711
Expiration Date: 2023-06-22
UPC: 05055844901551
The hazard
The FDA stated that individual components were labeled with incorrect colors, specifically swapping the red and green indicators for the EGR1 and control probes. This error causes the expected positive signal pattern for a 1x deleted 5q to appear as 1G2R instead of the correct 1R2G, resulting in an incorrect result.
Context
GovInfoNow's records show Cytocell Ltd. has 12 other recalls on record since March 15, 2019. Other recent recalls of similar products include the Cytocell RET Proximal Probe Recall (May 24, 2023), the Cytoc: BCL11B Reagent Recall (Oct. 27, 2022), and the Cytocell BCL11B Proximal Probe Mislabeling Risk (Oct. 27, 2022).
How to tell if you have this one
Check for the catalog number USA-LPH024 and lot number 075711. The kit expires June 22, 2023. The UDI code starts with (01)05055844901551(17)230622(10)075.
Brand
Cytoc:ell
Product
Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Labels
Verify the color labels on the probes; red should be for EGR1 and green for control.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 4 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of Hawaii, Missouri, Pennsylvania, Tennessee.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Hawaii, Missouri, Pennsylvania, Tennessee.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0741-2022 (January 18, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0741-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.