“Cytocell TCL1 Breakapart Probe Recall: Unexpected DNA signals risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/61180-cytocell-tcl1-breakapart-probe-recall-unexpected-dna-signals-risk. Based on FDA recall #Z-0814-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0814-2022%22&limit=1).
The FDA announced on Feb. 4, 2022, that Cytocell Ltd. voluntarily recalled one unit of its TCL1 Breakapart Probe due to a Class III hazard. The device may show unexpected locus specific signals in addition to those at 14q32.
How to tell if you have it
Brand: Cytocell
Product: TCL1 Breakapart Probe
Catalog Number: LPH046-A
Lot Code: 074612
Quantity: 1 unit
The hazard
The recall record states the probe may show unexpected locus specific signals in addition to those at 14q32. The FDA classified this as a Class III recall.
Context
GovInfoNow's records show Cytocell Ltd. has 12 other recalls on record since March 15, 2019. Other recent recalls of similar products include Exploro Fertility Test Recall (Nov. 22, 2025), Changchun Wancheng Bio-Electron UTI Test Strips Recall (Nov. 22, 2025), and Changchun Wancheng Male Fertility Sperm Test Cassette Recall (Nov. 22, 2025).
How to tell if you have this one
Check for catalog number LPH046-A and lot number 074612 on the product. The probe is used in fluorescence in situ hybridisation (FISH) genetic testing.
Brand
Cytoc:ell
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for catalog number LPH046-A and lot number 074612 on the probe.
Where it went and when
Where it was distributed
Distributed in Minnesota.
Listed by the agency
Not listed
FDA distribution: “MN” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Minnesota.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
1Firm started the recall
2FDA classified it Class III
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-0814-2022 (February 4, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0814-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.