FDA recall Z-1947-2024

LEICA BIOSYSTEMS NUSSLOCH GMBH · Class II · device

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

Status
Ongoing
Initiation date
2024-04-10
Report date
2024-06-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Nussloch, N/A, Germany

Primary source

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