Cytocell recalls a T-cell malignancy test probe due to incorrect chromomap in package inserts. This may affect lab results but does not pose immediate safety risks.
Device is mislabeled. The package insert for this ASR device contains a chromomap - an image showing the position the FISH probe maps to on the specific chromosome. For this device the chromomap in version 1 of the package insert is incorrect and doesn't not match the probe design or specification contained on the package insert
Cytocell is recalling a specific lab test probe for T-cell related malignancy because its package insert contains an incorrect chromomap. This could lead to inaccurate lab results but does not pose a direct safety risk to users.
The package insert for this lab probe includes a chromomap that doesn't match the actual probe design. This mismatch could cause inaccurate lab results when testing for T-cell related malignancies.
Lab technicians and researchers using the CytoCell BCL11B Proximal probe for T-cell malignancy testing are most at risk. The recall affects specific lab reagents with the model reference MPD39781.
Check for the model reference MPD39781 on the package or label. The product was sold with lot number RD22/230/10.
Look for the model reference MPD39781 and lot number RD22/230/10 on the product label.
No, the recall is for potential inaccurate lab results, not a safety hazard.
The official notice does not specify a remedy, so check with your lab supplier for guidance.
Look for the model reference MPD39781 and lot number RD22/230/10 on the product label.
We’ve drafted a message you can send Cytoc: a company name from the title to request your refund or repair — edit it as you like.
Subject: Recall Z-0353-2023 — Cytoc: a company name from the title Cytoc: a company name from the title Hello, I own a Cytoc: a company name from the title that is covered by recall Z-0353-2023 from Cytoc: a company name from the title. 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.
