“Cytoc: LPH019-A E2A Breakapart Probe Recall - Unexpected signals in tests.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62469-cytoc-lph019-a-e2a-breakapart-probe-recall-unexpected-signals-in. Based on FDA recall #Z-2323-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2323-2021%22&limit=1).
The FDA announced on May 27, 2021, that Cytocell Ltd. is recalling its Cytocell LPH019-A E2A (TCF3) Breakapart Probe reagents due to potential testing errors. The agency classified the recall as Class II.
How to tell if you have it
Brand: Cytocell
Product: Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Lot codes: 073004 and 072518 (Probe lot 200918-006)
Quantity: 23 units
Distribution: US Nationwide in CA, IL, KY, NY, OH, TX, UT, VA
The hazard
The reagents may show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34.
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), Changchun Wancheng Bio-Electron UTI Test Strips Recall (Nov. 22, 2025), and Exploro Fertility Test Recall (Nov. 22, 2025).
How to tell if you have this one
Check the lot number on the reagent packaging. Affected lots are 073004 and 072518 (Probe lot 200918-006).
Brand
Cytocell
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Lot Number
Look for lot numbers 073004 or 072518 on the reagent packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 8 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CA, IL, KY, NY, OH, TX, UT, VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Illinois, Kentucky, New York, Ohio, Texas, Utah, Virginia.
Recall timeline
FDA terminated this recall 11 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-2323-2021 (May 27, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2323-2021 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.