Z-1947-2024 Class II Ongoing
FDA device recall Z-1947-2024 was initiated by LEICA BIOSYSTEMS NUSSLOCH GMBH on April 10, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 141 devices.
Recall Details
- Product Type
- Devices
- Report Date
- June 12, 2024
- Initiation Date
- April 10, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 141 devices
Product Description
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 Pattern
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.
Code Information
All devices with serial numbers: G0061 - G0154, G0156 - G0530, G0532 - G0779, G0781, G0782; UDI-DI 04049188216397.