LEICA BIOSYSTEMS NUSSLOCH GMBH: Medical Device Recall in 2024 - (Recall #: Z-1947-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.

Product Classification:

Class II

Date Initiated: April 10, 2024

Date Posted: June 12, 2024

Recall Number: Z-1947-2024

Event ID: 94470

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.

Status: Ongoing

Product Quantity: 141 devices

Code Information:

All devices with serial numbers: G0061 - G0154, G0156 - G0530, G0532 - G0779, G0781, G0782; UDI-DI 04049188216397.

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.

Voluntary or Mandated:

Voluntary: Firm initiated