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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86084

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
July 17, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Cytocell Ltd.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The 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.

Z-2829-2020
Recall number
Z-2829-2020
Initiated
July 17, 2020
Classification
Class II
Status
Terminated
Recalling firm
Cytocell Ltd.
Quantity
62 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

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Inspect official wording and provenance

Reason for recall

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.

Code information

Lot numbers: 069915, 070433, 069305, 069468

Distribution pattern

Worldwide distribution - US Nationwide distribution and the country of Canada.