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.
Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34.
Cytocell is recalling specific reagents used in genetic testing that might show false signals at 9q34. This could lead to incorrect test results if the reagent is used without proper validation.
The reagent may show additional signals at 9q34 during testing, even though the product label states it has no cross-reactivity to that region. This could cause false positive results in genetic analyses.
Researchers and lab technicians using the Chromosome X Alpha-Satellite reagent (model MPA3481) for genetic analysis are most at risk. The recall affects specific lots of the reagent.
Check for the model number MPA3481 on the reagent packaging. The affected lots are RD20/253/16, RD21/043/01, and RD21/043/02.
Look for the lot numbers RD20/253/16, RD21/043/01, or RD21/043/02 on the reagent packaging.
The reagent may show additional signals at 9q34 during testing, even though the product label states it has no cross-reactivity to that region.
Check the lot number on the packaging. If it matches the affected lots (RD20/253/16, RD21/043/01, or RD21/043/02), contact Cytocell for guidance.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send Cytocell to request your refund or repair — edit it as you like.
Subject: Recall Z-1493-2021 — Cytocell Cytocell Hello, I own a Cytocell that is covered by recall Z-1493-2021 from Cytocell. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
