Reported Aug 26, 2020 · Terminated

Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a…

Cytocell Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cytocell Ltd. · 418 Cambridge Science Park, Milton Road · Cambridge, N/A · N/A

Is this the product you have?

  • Cytocell LPH533-A NUP98
  • Distal Probe Green - Product UsageThe NUP98 Distal probe, labelled in green, consists of a 151kb probe distal to the NUP98 gene, covering the ZNF195 gene and the D11S4731 marker. Fluorescence in situ hybridisation (FISH) is a technique that allows the visualisation of DNA sequences upon chromosomes
Lot codes and dates
  • Lot numbers
    • 069915
    • 070433
    • 069305
    • 069468
Amount recalled
62 units

Where it was sold

  • Nationwide

Why it was recalled

A low risk of a false positive result being issued with a laboratory developed test (LDT) that utilizes the LPH533-A NUP98 Distal Probe Green.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 30, 2020 · Data as of Sep 19, 5:23 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.