Cytocell LPH533-A NUP98 Distal Probe Green: Low Risk of False Positive Results

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Contact the company & request your remedy

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

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Cytocell is recalling a specific lab probe that may cause false positive results in certain genetic tests. This does not pose a safety risk but could lead to incorrect test outcomes.

Why it’s dangerous

The probe may produce false positive results when used with laboratory-developed tests (LDTs) that detect specific genetic markers. This could lead to incorrect diagnoses or treatment decisions.

Who’s affected

Lab technicians and healthcare providers using the Cytocell LPH533-A NUP98 Distal Probe Green for genetic testing are most at risk of inaccurate results.

How to tell if you have this one

Check for the green label on the probe. Affected units have lot numbers: 069915, 070433, 069305, or 069468.

Brand
Cytocell
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Lot Number
Verify the lot number on the probe to see if it matches the affected numbers: 069915, 070433, 069305, or 069468.

✎ GovInfoNow

Questions people ask

Is this product dangerous?

No, this is a low-risk issue that could cause false positive results in specific lab tests but does not pose a safety hazard.

What should I do if I have this probe?

Check the lot number to see if it's affected. If it matches the listed numbers, you may need to contact Cytocell for guidance.

How do I know if my probe is affected?

The affected probes have a green label and specific lot numbers: 069915, 070433, 069305, or 069468.

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-2829-2020 — Cytocell Cytocell

Hello,

I own a Cytocell that is covered by recall Z-2829-2020 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-2829-2020 (July 17, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2829-2020 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 LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a

Lower-risk recall