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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82917

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

Open FDA event record

Event summary

Timeline bucket
April 26, 2019
Product types
Device
Classifications
Class III
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

Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The 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.

Z-1843-2019
Recall number
Z-1843-2019
Initiated
April 26, 2019
Classification
Class III
Status
Terminated
Recalling firm
Cytocell Ltd.
Quantity
400

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is an error in the chromomap on the package insert.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Numbers: 058585, 061111, 061354, 062527

Distribution pattern

Worldwide Distribution - US Nationwide AL, CO, FL, HI, IA, IL, IN, KY, MA, MD, MI, MO, MS, NC, NJ, NY, TN, TX, UT, WA, and WI. The products were distributed to the following foreign countries: Canada.