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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94470

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

Open FDA event record

Event summary

Timeline bucket
April 10, 2024
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 Tissue Processor, REF 14048858005.

Z-1947-2024
Recall number
Z-1947-2024
Initiated
April 10, 2024
Classification
Class II
Status
Ongoing
Quantity
141 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent levels exceeding the maximum fill level marks on reagent bottles or in the paraffin tanks.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent levels exceeding the maximum fill level marks on reagent bottles or in the paraffin tanks.

Code information

All devices with serial numbers: G0061 - G0154, G0156 - G0530, G0532 - G0779, G0781, G0782; UDI-DI 04049188216397.

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NJ, NV, NY, OH, TN, TX, UT, VA, WA, and WI. There was also government distribution but no military distribution. The country of Canada.

Field note

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