Cytocell TCL1 Breakapart Probe Recall: Unexpected DNA signals risk

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Recalling firmCytocell Ltd.418 Cambridge Science Park, Milton Road, Oxford Gene Technology · Cambridge, N/A N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Cytocell is recalling its TCL1 Breakapart Probe due to a risk of showing unexpected DNA signals. This could lead to inaccurate results in genetic testing. Affected users should check their product details and contact Cytocell for guidance.

Why it’s dangerous

The probe may show extra DNA signals at 14q32, which could cause false results in genetic tests. This happens due to the probe's design for visualizing DNA sequences on chromosomes.

Who’s affected

Users of the TCL1 Breakapart Probe for genetic testing are most at risk. This product is used by researchers and labs handling DNA analysis.

How to tell if you have this one

Check for catalog number LPH046-A and lot number 074612 on the product. The probe is used in fluorescence in situ hybridisation (FISH) genetic testing.

Brand
Cytoc:ell
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for catalog number LPH046-A and lot number 074612 on the probe.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall does not state if the product is safe; it only mentions a potential risk of unexpected signals.

How can I tell if I have the recalled product?

Check for catalog number LPH046-A and lot number 074612 on the TCL1 Breakapart Probe.

What should I do if I have the recalled product?

The recall record does not specify a remedy, so contact Cytocell directly for guidance.

Take action

Contact Cytoc:ell

We’ve drafted a message you can send Cytoc:ell to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0814-2022 — Cytoc:ell Cytoc:ell

Hello,

I own a Cytoc:ell that is covered by recall Z-0814-2022 from Cytoc:ell.

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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Where this comes from

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-0814-2022 (February 4, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0814-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.

Cytocell Ltd. recalls TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA

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