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.
“Cytocell LPH533-A NUP98 Distal Probe Green: Low Risk of False Positive Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64694-cytocell-lph533-a-nup98-distal-probe-green-low-risk-of. Based on FDA recall #Z-2829-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2829-2020%22&limit=1).
The FDA announced on July 17, 2020, that Cytocell Ltd. is recalling the LPH533-A NUP98 Distal Probe Green due to a low risk of false positive results in laboratory developed tests. The agency issued recall number Z-2829-2020 for the Class II device.
How to tell if you have it
Brand: Cytocell
Product: LPH533-A NUP98 Distal Probe Green
Lot numbers: 069915, 070433, 069305, 069468
Quantity: 62 units
The hazard
According to the FDA, the recall addresses a low risk of a false positive result being issued with a laboratory developed test that utilizes the LPH533-A NUP98 Distal Probe Green. The probe is used in fluorescence in situ hybridisation (FISH) to visualize DNA sequences upon chromosomes.
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), S. Typhi/Para Ty false test results risk (Nov. 22, 2025), and Changchun Wancheng Bio-Electron UTI Test Strips Recall (Nov. 22, 2025).
How to tell if you have this one
Check for the green label on the probe. Affected units have lot numbers: 069915, 070433, 069305, or 069468.
Brand
Cytocell
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Lot Number
Verify the lot number on the probe to see if it matches the affected numbers: 069915, 070433, 069305, or 069468.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution and the country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2 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-2829-2020 (July 17, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2829-2020 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.