# FDA recall Z-1947-2024

> **LEICA BIOSYSTEMS NUSSLOCH GMBH** · Class II · device recall initiated 2024-04-10.

## Product

Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.

## 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.

## Distribution

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.

## Key facts

- **Recall number:** Z-1947-2024
- **Recalling firm:** LEICA BIOSYSTEMS NUSSLOCH GMBH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-10
- **Report date:** 2024-06-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Nussloch, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1947-2024

## Citation

> AI Analytics. FDA recall Z-1947-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1947-2024. Source: US FDA. Licensed CC0.

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