Lower riskMedical device recall · FDA · Published December 22, 2020
Cytocell Aquarius LPH 511-A CRLF2 Distal Probe Green: Low Risk of False Test Results
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.
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.
Take action
Contact the company
📍Recalling firmCytocell Ltd.418 Cambridge Science Park, Milton Road, Oxford Gene Technology · Cambridge, United Kingdom
“Cytocell Aquarius LPH 511-A CRLF2 Distal Probe Green: Low Risk of False Test Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63624-cytocell-aquarius-lph-511-a-crlf2-distal-probe-green-low. Based on FDA recall #Z-1099-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1099-2021%22&limit=1).
Cytocell Ltd. recalled the Aquarius LPH 511-A CRLF2 Distal Probe Green on Dec. 22, 2020, according to the FDA. The device may produce faint additional signals, risking incorrect test results in laboratory developed tests.
How to tell if you have it
Brand: Cytocell
Product: Aquarius LPH 511-A CRLF2 Distal Probe Green
Model no.: LPH 511-A
Lots: 072240, 071390, and 072693
The hazard
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.
Context
GovInfoNow's records show Cytocell Ltd. has 12 other recalls on record since March 15, 2019. Other recent recalls of similar products include LH One Step Ovulation Test Device Recall (Nov. 22, 2025), Meridian Bioscience Revogene C. difficile Test Recall (Dec. 5, 2025), and Changchun Wancheng Bio-Electron UTI Test Strips Recall (Nov. 22, 2025).
How to tell if you have this one
Look for the Aquarius LPH 511-A CRLF2 Distal Probe Green, model number LPH 511-A. The product was sold in lots 072240, 071390, and 072693.
Brand
Cytocell
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Lot Number
Verify the lot number on the probe to see if it matches 072240, 071390, or 072693.
Where it went and when
Where it was distributed
Distributed in 7 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Domestic distribution to California, Illinois, Michigan, Minnesota, New Jersey, Texas, and Washington. Foreign distribution to Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Illinois, Michigan, Minnesota, New Jersey, Texas, Washington.
Recall timeline
FDA terminated this recall 17 months 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-1099-2021 (December 22, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1099-2021 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.