Reported Jun 26, 2019 · Terminated

Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D13S319 probe, labelled in red, covers a 156kb…

Cytocell Ltd.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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?

  • Aquarius D13S319 Plus Deletion Probe
  • Model LPH068-A Product UsageThe D13S319 probe, labelled in red, covers a 156kb region including most of the DLEU2 gene, part of the DLEU1 gene and the D13S319 and D13S272 markers. The 13qter subtelomere specific probe, labelled in green, allows identification of chromosome 13 and acts as a control probe
Lot codes and dates
  • Lot Numbers
    • 058585
    • 061111
    • 061354
    • 062527
Amount recalled
400

Where it was sold

Why it was recalled

There is an error in the chromomap on the package insert.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 16, 2020 · Data as of Sep 19, 5:40 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.