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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89669

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

Open FDA event record

Event summary

Timeline bucket
February 04, 2022
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

TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A

Z-0814-2022
Recall number
Z-0814-2022
Initiated
February 04, 2022
Classification
Class III
Status
Terminated
Recalling firm
Cytocell Ltd.
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
May show unexpected locus specific signals in addition to those at 14q32.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

May show unexpected locus specific signals in addition to those at 14q32.

Code information

Lot 074612

Distribution pattern

MN