Lower riskMedical device recall · FDA · Published May 17, 2021
Cytocell DiGeorge Probe Recall: Unexpected signals in genetic testing
Cytocell recalls DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe (Model LPU004-A) due to potential for unexpected genetic signals in testing. Affected lots: 071399, 072985.
The device may show unexpected locus specific signals in addition to those at 22q. Users may observe faint additional locus specific signals at 20p12/13.
Take action
Contact the company
📍Recalling firmCytocell Ltd.418 Cambridge Science Park, Milton Road, Oxford Gene Technology · Cambridge, United Kingdom
“Cytocell DiGeorge Probe Recall: Unexpected signals in genetic testing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62536-cytocell-digeorge-probe-recall-unexpected-signals-in-genetic-testing. Based on FDA recall #Z-2134-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2134-2021%22&limit=1).
The FDA announced on May 17, 2021, that Cytocell Ltd. voluntarily recalled the CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. The device may show unexpected locus-specific signals, potentially leading to incorrect diagnostic results.
How to tell if you have it
Brand: Cytocell
Product: CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe
Model Number: LPU004-A
Lot Numbers: 071399, 072985
Quantity: 50 units
The hazard
The device may show unexpected locus-specific signals in addition to those at 22q. Users may observe faint additional locus-specific signals at 20p12/13.
Context
GovInfoNow's records show Cytocell Ltd. has had 12 other recalls since March 15, 2019. Recent brand recalls include a May 24, 2023 recall for RET Proximal Probe due to DNA inversion risk and two October 27, 2022 recalls for BCL11B Reagent and Proximal Probe involving chromomap errors and mislabeling. Other recent recalls of similar products include Exploro Fertility Test Recall (Nov. 22, 2025), Changchun Wancheng Male Fertility Sperm Test Cassette Recall (Nov. 22, 2025), and Changchun Wancheng Bio-Electron UTI Test Strips Recall (Nov. 22, 2025).
How to tell if you have this one
Check if you have the Cytocell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe with model number LPU004-A. Look for lot numbers 071399 or 072985 on the packaging.
Brand
Cytocell
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Lot Number
Look for lot numbers 071399 or 072985 on the probe packaging.
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: “Distribution to US states of CA, IL, MO, NY, PA, TX, and UT, and Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Illinois, Missouri, New York, Pennsylvania, Texas, Utah.
Recall timeline
FDA terminated this recall 15 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-2134-2021 (May 17, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2134-2021 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.