Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
Reported: June 12, 2024 Initiated: April 10, 2024 #Z-1947-2024
Product Description
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.
Details
- Recalling Firm
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Units Affected
- 141 devices
- 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.
- Location
- Nussloch, N/A
Frequently Asked Questions
What product was recalled? ▼
Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.. Recalled by LEICA BIOSYSTEMS NUSSLOCH GMBH. Units affected: 141 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 12, 2024. Severity: Moderate. Recall number: Z-1947-2024.
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