FDAFDA · Food and drugs·Recall number Z-1947-2024
Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
Published June 12, 2024 · Recall initiated: April 10, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Distributor
- 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.
- Lot
- All devices with serial numbers: G0061 - G0154, G0156 - G0530, G0532 - G0779, G0781, G0782; UDI-DI 04049188216397.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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