Cytocell DiGeorge Probe Recall: Unexpected signals in genetic testing

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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 a genetic testing probe that may show unexpected signals during analysis. This could lead to inaccurate results in DiGeorge/VC:FS syndrome testing. Affected units have specific lot numbers.

Why it’s dangerous

The probe may display faint additional signals at 20p12/13 locations during testing, which could cause misinterpretation of genetic results. This might lead to incorrect diagnoses for conditions like DiGeorge/VCFS syndrome.

Who’s affected

Genetic testing labs and healthcare providers using the Cytocell DiGeorge/VCFS probe for in vitro diagnostics. Those with the specific lot numbers 071399 or 072985 are most at risk.

How to tell if you have this one

Check if you have the Cytocell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe with model number LPU004-A. Look for lot numbers 071399 or 072985 on the packaging.

Brand
Cytocell
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for lot numbers 071399 or 072985 on the probe packaging.

✎ GovInfoNow

Questions people ask

What is the specific model number of the recalled probe?

The model number is LPU004-A.

Which lot numbers are affected?

Lot numbers 071399 and 072985.

Why is this probe being recalled?

The probe may show unexpected signals at 20p12/13 locations during genetic testing, potentially causing misdiagnosis.

Take action

Contact Cytocell

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

✉️ Open in email

Subject: Recall Z-2134-2021 — Cytocell Cytocell

Hello,

I own a Cytocell that is covered by recall Z-2134-2021 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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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-2134-2021 (May 17, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2134-2021 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.

Cytocell Ltd. recalls CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in

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