FDA-Device2024-06-12Class II
Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
LEICA BIOSYSTEMS NUSSLOCH GMBH
Hazard
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.
Sold states
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.
Affected count
141 devices
Manufactured in
Heidelberger Str. 17-19, N/A, Nussloch, N/A, Germany
Products
Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1947-2024Don't want to check this manually?
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