Lower riskMedical device recall · FDA · Published March 19, 2021
Cytocell Chromosome X Alpha-Satellite Reagent Recall: Potential False Signals
Cytocell recalls Chromosome X Alpha-Satellite in FITC Spectrum reagents (model MPA3481) due to possible false signals at 9q3: users may see extra locus-specific signals despite no cross-reactivity claims.
“Cytocell Chromosome X Alpha-Satellite Reagent Recall: Potential False Signals.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63023-cytocell-chromosome-x-alpha-satellite-reagent-recall-potential-false-signals. Based on FDA recall #Z-1493-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1493-2021%22&limit=1).
The FDA announced on March 19, 2021, that Cytocell Ltd. is recalling Chromosome X Alpha-Satellite in FITC Spectrum (Model MPA3481) because users may observe additional locus specific signals at 9q34. The agency issued recall number Z-1493-2021 for the voluntary Class II action.
How to tell if you have it
Brand: Cytocell
Product: Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents
Model: MPA3481
Lots: RD20/253/16, RD21/043/01, RD21/043/02
Quantity: 89 probes
The hazard
According to the FDA, users may observe additional locus specific signals at 9q34 when using the device. The device pack insert indicates that the probe has no known cross-reactivity to 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 Foundation Medicine Sequencing Agent SEQ0067 Recall (March 20, 2026), Changchun Wancheng Bio-Electron UTI Test Strips Recall (November 22, 2025), and Exploro Fertility Test Recall (November 22, 2025).
How to tell if you have this one
Check for the model number MPA3481 on the reagent packaging. The affected lots are RD20/253/16, RD21/043/01, and RD21/043/02.
Brand
Cytocell
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Reagent Lot Number
Look for the lot numbers RD20/253/16, RD21/043/01, or RD21/043/02 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 TX, OH, NY, IL, CT, AL, IA, MO.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Connecticut, Illinois, Iowa, Missouri, New York, Ohio, Texas.
Recall timeline
FDA published this recall 47 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-1493-2021 (March 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1493-2021 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.