Medical Device Recall: Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
LEICA BIOSYSTEMS NUSSLOCH GMBH · April 10, 2024
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.
States Affected
NATIONWIDE
Quantity Affected
141 devices
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1947-2024
Status: ongoing
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