Home / Recalls / Medical Devices
LEICA BIOSYSTEMS NUSSLOCH GMBH recalls Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
Recalled June 12, 2024 · FDA recall Z-1947-2024 · LEICA BIOSYSTEMS NUSSLOCH
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. · FDA Class II
Units
141 devices
Sold at
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.
Description
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.
Product
Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
Manufacturer(s)
LEICA BIOSYSTEMS NUSSLOCH GMBH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →