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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93467

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

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Event summary

Timeline bucket
November 20, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
LEICA BIOSYSTEMS NUSSLOCH GMBH

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

Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)

Z-0590-2024
Recall number
Z-0590-2024
Initiated
November 20, 2023
Classification
Class II
Status
Ongoing
Quantity
98 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoCore PEGASUS / HistoCore PEGASUS Plus resulting from an incorrect assignment of the carryover value set for created or edited protocols.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

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Inspect official wording and provenance

Reason for recall

There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoCore PEGASUS / HistoCore PEGASUS Plus resulting from an incorrect assignment of the carryover value set for created or edited protocols.

Code information

All devices with serial number: G0061-G0701

Distribution pattern

US, Nationwide