Cytocell recalls specific lab reagents that may show unexpected signals in genetic tests. Affected lots: 073004 and 072518 (Probe lot 200918-006).
May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34
Cytocell is recalling a specific lab reagent that may show unexpected genetic signals during testing. This could lead to inaccurate results if users see faint additional signals at 9q34.
The reagents may produce faint additional signals at 9q34 during genetic testing, which could lead to inaccurate results. This happens due to the specific reagent design and may not cause physical harm but could affect test accuracy.
Lab users who purchased the Cytocell LPH019-A E2A (TCF3) Breakapart Probe reagents with lots 073004 or 072518 are affected. Those performing genetic tests using these reagents are most at risk.
Check the lot number on the reagent packaging. Affected lots are 073004 and 072518 (Probe lot 200918-006).
Look for lot numbers 073004 or 072518 on the reagent packaging.
The reagents may show faint additional signals at 9q34 during genetic testing, which could lead to inaccurate results.
Lots 073004 and 072518 (Probe lot 200918-006).
No specific stop-use instruction is given; check the lot number to see if affected.
We’ve drafted a message you can send Cytocell to request your refund or repair — edit it as you like.
Subject: Recall Z-2323-2021 — Cytocell Cytocell Hello, I own a Cytocell that is covered by recall Z-2323-2021 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.
